Overview of FDA Warning Letters regarding the Manufacture of Sterile Medicinal Products

Warning Letters are documents sent by the US Food and Drug Administration (FDA) in cases of serious GMP deviations or wrong behaviours of companies to observed deficiencies. To avoid further severe consequences, companies have to send the FDA a list within 15 working days comprising the measures to remedy these deviations. In the context of the Freedom of Information Act (FOI), the FDA regularly publishes these Warning Letters on its website.

During fiscal year 2011, several Warning Letters issued included deficiencies regarding the manufacture of sterile medicinal products. Warning Letters always refer the observed deficiencies to the legal requirements laid down in 21 CFR Part 210 / 211. As expected, most deviations with regard to the manufacture of sterile medicinal products concerned the following three areas:

  • Control of microbiological contamination
  • Production record review
  • Design and construction features

A compilation of the Warning Letters from fiscal year 2011 as well as from the years before can be found on the ECA Homepage.

Please also see the FDA Warning Letters webpage.

Dr Andreas Mangel
CONCEPT HEIDELBERD (a service provider entrusted by the ECA Foundation)

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