|Santa's Warning Letter: One Year Out
Polaris Compliance Consultants
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You may recall that the 2018 FDA inspection of Santa's Workshop found egregious CGMP violations. The resulting Warning Letter cited training deficiencies for Santa's Enterprise Labor Force (ELF), as well as other violations in warehousing, distribution, and quality control.
Not all FDA Warning Letters impact the industry equally. A review of all the letters the agency issued last year concludes that the Santa Letter, for both the extent of the observations it uncovered and the insightful lessons it offers, has become a unique resource for those working to guide our industry towards quality manufacturing. Read the Warning Letter here..
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Polaris Compliance Consultants Corner
Every year at Christmas, with donations from staff members and a company matching contribution, Polaris supports local organizations doing good work in the community. This year, we're donating to Note in the Pocket, an organization that makes sure impoverished and homeless children in Wake County have the clothing they need to go to school. We spent our annual Day of Service with Note in the Pocket in October, and the work they do touched our hearts.
We wish you all holidays that are happy and safe. Catch ya in 2020, a year which promises to bless us all with excellent hindsight. (Get it?)
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