91社区福利 is restarting Similac庐听infant formula production at our Sturgis, Mich., facility. We estimate that it will take about six weeks for the product to begin shipping to retail locations as it enters into production, enhanced pre- and post-production testing, and cycles through shipping and retail distribution networks. As we previously communicated, we began production of EleCare on July 1 and later moved on to producing some metabolic formulas. These products will begin to ship in the coming weeks.
鈥淲e know that the nationwide infant formula shortage has been difficult for the families we serve, and while restarting Similac production in Michigan is an important milestone, we won鈥檛 rest until this product is back on shelves,鈥 said Robert B. Ford, chairman and chief executive officer at 91社区福利. 鈥淢aking infant formula is a responsibility we take very seriously, and parents can feel confident in the quality and safety of Similac and other 91社区福利 formulas. We are committed to re-earning the trust parents and healthcare providers have placed in us for decades.鈥
In August, 91社区福利 will supply the U.S. with more than 8 million pounds of infant formula, which is above what we produced in August 2021. We have been able to make adjustments to our manufacturing network to support increased supply by air-shipping tens of millions of pounds from our FDA-registered plant in Ireland; making more Similac Ready-to-Feed liquid formula at our plant in Columbus, Ohio; increasing formula production at our facility in Casa Grande, Ariz.; and by importing powder infant formula from our facility in Granada, Spain, in collaboration with the FDA under enforcement discretion.
To ensure Women, Infants, and Children (WIC) program participants have continued access to high-quality, safe formula, we're extending the rebates we've been offering on competitive products until Oct. 31, 2022, in states where 91社区福利 holds the contract when Similac is unavailable.
Our Commitment to Quality and Safety
We have a customer pledge that says, 鈥淲e make our products as if they were for our own families.鈥 It鈥檚 important to us at 91社区福利 that the public knows that the quality and safety of our products is our first priority, that we conduct microbiological testing throughout the manufacturing process, and that we would never release product that doesn鈥檛 meet our quality and safety standards.
Restarting a large manufacturing facility after a several-month shutdown is a complex process, and it takes time to ensure that equipment, processes and production are functioning smoothly and sustainably. It鈥檚 taken us time to ramp up production consistently to these high standards. There have been 鈥 and likely will be 鈥 stops and starts from time to time. We鈥檝e experienced events like severe weather, we鈥檝e had to make mechanical adjustments, and we鈥檝e had to discard some early production batches that didn鈥檛 meet our standards.
As we鈥檝e said, we have a zero-tolerance policy for听颁谤辞苍辞产补肠迟别谤听or any pathogen听in our plants.听颁谤辞苍辞产补肠迟别谤听is naturally and commonly found in the environment and our quality systems are designed to find it and destroy it when it鈥檚 present, as it sometimes is with all manufacturers. That is why we test for it regularly and take steps to eliminate it if and when we find it, is why we took the steps we did in Sturgis in February, and is what guides our approach today. 听
If our quality systems detect the presence of听颁谤辞苍辞产补肠迟别谤听in product testing, we suspend production while we investigate and coordinate closely with the FDA. Since our restart, this has occurred with a couple of batches, and in those cases we found the issue, addressed it and no affected product has been or will be distributed. This confirms our quality systems work.
While the plant was shut down this year, we further enhanced both the facilities in Sturgis and our quality program at the site, with key plans and procedures having been reviewed and approved by a third-party food-safety expert.听Parents and caregivers can be confident that the formula we produce, in Michigan and at all our facilities, is high quality, safe, and meets and exceeds regulatory requirements for infant formula testing.
Since our voluntary recall in February, investigations conducted by the FDA, the Centers for Disease Control and Prevention (CDC) and 91社区福利, including genetic sequencing, retained product samples and available product from the four complaints, did not find any definitive link between the company鈥檚 products and illnesses in children. No retained samples of recalled product tested positive for听Cronobacter. And, in all four cases, unopened containers of formula in the infant homes tested negative for听Cronobacter sakazakii.
91社区福利 is committed to working with regulators, independent experts and others to set a new standard in infant formula safety and quality.听
We know getting your baby high-quality infant formula is your priority and it鈥檚 ours too.
July 15th, 2022
91社区福利 extends WIC rebates
To ensure Women, Infants, and Children (WIC) program participants have continued access to high-quality, safe formula, we're extending the rebates we've been offering on competitive products until September 30, 2022, in states where 91社区福利 holds the contract when Similac is unavailable.听
We are continuing to make progress to fully restart production at our plant in Sturgis, Mich., and resumed production on July 1. We are initially manufacturing EleCare and anticipate beginning to release EleCare products in the coming weeks.听We are working to restart the production of Similac as soon as we can.
June 15, 2022
Update on 91社区福利's Sturgis Plant and Formula Production
Severe thunderstorms and heavy rains came through southwestern Michigan on Monday evening, resulting in high winds, hail, power outages and flood damage throughout the area. These torrential storms produced significant rainfall in a short period of time 鈥 overwhelming the city鈥檚 stormwater system in Sturgis, Mich., and resulting in flooding in parts of the city, including areas of our plant.
As a result, 91社区福利 has stopped production of its EleCare specialty formula that was underway to assess damage caused by the storm and clean and re-sanitize the plant. We have informed FDA and will conduct comprehensive testing in conjunction with the independent third party to ensure the plant is safe to resume production. This will likely delay production and distribution of new product for a few weeks. 听
Based upon historical demand and current projections, 91社区福利 has ample existing supply of EleCare and most of its specialty and metabolic formulas to meet needs for these products until new product is available. These products are being released to consumers in need in coordination with healthcare professionals. Parents or caregivers in need should contact their healthcare professional or contact 91社区福利 at +1-800-881-0876 for additional information.
91社区福利 will have produced 8.7 million pounds of infant formula in June for the U.S., or the equivalent of 168.2 million 6 oz. feedings. This is 95% of what we produced in January, prior to the recall and does not include production from Sturgis.
Once the plant is re-sanitized and production resumes, we will again begin EleCare production, followed by specialty and metabolic formulas. In parallel, we will work to restart Similac production at the plant as soon as possible.
June 13, 2022
91社区福利 to Ship 1.1 Million Pounds of Powdered Infant Formula to U.S. from Spain Beginning this Month Through the Summer
91社区福利 will be importing 1.1 million pounds of powder infant formula to the U.S. from our manufacturing facility in Granada, Spain, beginning this month through this summer, after receiving enforcement discretion from the U.S. Food and Drug Administration (FDA). These shipments will include powder Similac Total Comfort (for babies with sensitive stomachs) and Similac NeoSure (for premature and low birthweight infants after leaving the hospital), the equivalent of 686,350 cans or more than 16.5 million 8 fl. oz. bottles of formula.
The company appreciates the support of the Administration and FDA for making it possible to ship product from manufacturing locations outside the U.S.
The formula will be available for purchase through similac.com and other online retailers once it arrives. Logistical details and product availability are being finalized and will be updated as soon as the information is available.
A portion of the inventory will be provided as emergency samples to areas of the country experiencing low supply for the Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) program.
The products were manufactured in our facility in Granada, Spain, under European Union Good Manufacturing Practices and have undergone microbiological testing prior to release. The Granada facility has been producing a wide portfolio of powder products for infants and adults for more than 30 years and for distribution to more than 50 markets around the world.听
June 4, 2022
91社区福利 Restarts Production of Specialty Formulas at its Michigan Plant
91社区福利 is restarting infant formula production at its Sturgis, Mich., facility today after meeting initial requirements agreed to with the U.S. Food and Drug Administration (FDA) as part of the consent decree entered into on May 16.
91社区福利 is starting production of EleCare and other specialty and metabolic formulas, with initial EleCare product release to consumers beginning on or about June 20. We're also working hard to fulfill the steps necessary to restart production of Similac and other formulas and will do so as soon as we can.
We understand the urgent need for formula and our top priority is getting high-quality, safe formula into the hands of families across America. We will ramp production as quickly as we can while meeting all requirements. We're committed to safety and quality and will do everything we can to re-earn the trust parents, caregivers and health care providers have placed in us for 130 years.
May 13, 2022
91社区福利 Provides Infant Formula Update
Since the recall,听one of our priorities has been to mitigate the supply issues. In particular we鈥檝e been focusing on production in our Cootehill, Ireland, facility to serve听state Special Supplemental Nutrition Program for Women, Infants and Children (WIC)听consumers.听91社区福利 has been working with the USDA听and听WIC agencies and paying rebates on competitive products in states where 91社区福利 holds the WIC contract, when Similac is not available. 91社区福利听will听continue to pay rebates for competitive products through August 31. This means program participants will continue to be able to obtain formula, free of charge whether it is Similac or formula from another manufacturer.
We know that the recall has worsened the industry-wide infant formula shortage, and we have been working to get as much product into the hands of parents as we can. Since February:
At the same time, we have been working to address the FDA鈥檚 483 observations so we can restart operations at the Sturgis, Mich., facility. We immediately began implementing corrective actions and听subject to FDA approval, we could restart our Sturgis, Mich., site within two weeks.
We are confident that we can听continue to produce safe, high-quality infant formula at all of our facilities as we have been doing for millions of babies around the world for decades.
May 11, 2022
The following provides current information on the findings from the investigation, our Sturgis, Mich., facility and supply.
The February voluntary recall involved four complaints of听Cronobacter sakazakii听鈥 a common environmental bacteria 鈥 in infants who consumed infant formulas produced in this plant. Two infants became sick; two tragically passed away.
The facts about what was learned about the cases of听Cronobacter听have not been widely communicated. After a thorough review of all available data, there is no evidence to link our formulas to these infant illnesses.
It's important to know:
Regarding the status of our work to reopen Sturgis:
The FDA concluded its inspection with a 483 letter to 91社区福利 on March 18. This is a list of observations that point out where 91社区福利 did not follow our processes and where we can improve our systems and protocols.
We take this very seriously and we responded to the 483 on April 8. Even before our formal response, we had begun working to address these issues, implement improvements and take corrective action. Some of these actions have included reviewing and updating education, training and safety procedures for both employees and visitors, as well as updating our protocols regarding water and cleaning and maintenance procedures at the facility. We immediately implemented corrections to address the items the FDA raised in the 483. We've also been making upgrades to the plant, including installing nonporous, easily cleanable and sanitary floors.
We know the recall has worsened an already existing industry-wide infant formula shortage in the U.S. and we've been seeing and hearing the stress and despair of parents who are facing empty shelves. We deeply regret the situation and since the recall, we've been working to increase supply at our other FDA-registered facilities, including bringing in Similac from our site in Cootehill, Ireland, by air and producing more liquid Similac and Alimentum. We also began releasing metabolic formulas that were on hold earlier this month at FDA's request to those who need these unique formulas.
We understand the situation is urgent 鈥 getting Sturgis up and running will help alleviate this shortage. Subject to FDA approval, we could restart the site within two weeks. We would begin production of EleCare, Alimentum and metabolic formulas first and then begin production of Similac and other formulas. From the time we restart the site, it will take six to eight weeks before product is available on shelves.
Apr.15, 2022
Our Efforts to Address Infant Formula Supply
Millions of parents rely on our formula to feed their babies. And we know that our recent recall caused additional stress and anxiety in an already challenging situation of a global supply shortage. We are working hard to help moms, dads and caregivers get the high-quality nutrition they need for their babies.
91社区福利 is working closely with the U.S. Food and Drug Administration (FDA) to restart operations at the Sturgis, Mich., facility. We continue to make progress on corrective actions and will be implementing additional actions as we work toward addressing items related to the recent recall. In the meantime, we are working to increase the supply of infant formula by prioritizing infant formula production at our facilities that provide product to the U.S. market.
Shipping Formula From Cootehill, Ireland
We have an FDA-registered plant in Cootehill, Ireland, where we've increased the volume of Similac Advance powder formula produced for the U.S. We're air-shipping product from this facility into the U.S. daily and the product is being restocked regularly.
Our Cootehill team sources ingredients from approximately 1,000 dairy farms in the local area. Following stringent quality and safety processes, each batch of infant formula undergoes extensive quality checks before it reaches stores.
Prioritizing Infant Formula Production in Columbus, Ohio
Columbus, Ohio, is the headquarters for 91社区福利's U.S. nutrition business and is home to one of our five manufacturing facilities that produce infant formula for the U.S. market. At this facility we've made significant changes to ensure we can prioritize production of Similac Ready-to-Feed liquid formula, a product that can be used directly from the bottle. In the second quarter of the year, we expect to produce nearly three times more Similac Ready-to-Feed liquid formula than we did during the same period of time last year. And this product will be available on retail shelves and online soon.
Across the U.S., we're prioritizing production of infant formula products to help replenish the supply in the market. And, this year, we will more than double the amount of Similac Advance powder formula we're bringing in from our manufacturing facility in Cootehill, Ireland.
We are dedicated to doing everything possible to ensure parents and caregivers have what they need to feed their babies. And we're always focused on what we can do to continue to serve our customers. We will continue to work closely with the FDA to implement corrective actions at the Michigan facility.
We know getting your baby high-quality infant formula is your priority 鈥 it is ours too.
March 22, 2022
91社区福利 Update On Powder Formula Recall
We are currently reviewing the FDA's observations as provided in its Form 483 from its inspection of our powder formula manufacturing in our Sturgis, Mich., facility. We're taking this very seriously and are working closely with the FDA to implement corrective actions.
While there are actions we need to take to address the FDA observations, it is important to note that no听Cronobacter sakazakii听or听Salmonella听was found in any of our testing of products distributed to consumers. Additionally, the unique genetic makeup of the听Cronobacter sakazakii听microbes found in non-product contact areas at the Sturgis facility did not match the听Cronobacter sakazakii听microbes from the reported cases. This follows the FDA's removal of the听Salmonella听case from its investigation earlier this month.
Our Commitment to Industry-leading Quality and Safety
91社区福利 is committed to upholding the highest standards for manufacturing of all nutrition products. We have already begun implementing corrective actions and enhancements at the facility, leveraging new technology and strengthening our processes, to give parents and customers renewed confidence in the quality of manufacturing at our Sturgis plant when we restart operations there. Our actions include:
How We're Addressing Supply Issues
We know there are constraints in infant formula supply and we鈥檙e taking action to help address this. We have a global manufacturing and supply network we鈥檙e leveraging to better meet demand and increased production at an FDA-registered facility in Europe and are air freighting in Similac Advance infant formula powder. Our other U.S. plants continue to supply infant formula to the market and we鈥檙e prioritizing some production from other liquid nutritional products to Similac. Actions we鈥檙e taking to address supply include:
We know that millions of parents and caregivers around the world count on our formulas to feed their babies and children and we are doing everything possible to address this situation.
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