Maintaining Manufacturing Quality

Maintaining Manufacturing Quality

By Karl Kapp 


Quality or lack of quality in a manufacturing process can lead to warning letters and serious issues with the FDA. Here is a list of several infractions found in warning letters from 2016 related to manufacturing quality. The write-ups and issues in the warning letters should serve as a reminder to organizations that did not receive the letters to make sure that the manufacturing quality meets FDA standards to ensure safety for the health of everyone. In other words, look over your operations and ensure that these infractions are not occurring at your plant.


  • Failure to follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes. (21 CFR 211.113(b))
  • Failure to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups in aseptic processing areas. (21 CFR 211.42(c)(10))
  • Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed. (21 CFR 211.192)
  • Failure to adequately investigate and document out-of-specification results according to a procedure, and implement appropriate corrective actions.
  • Failure of the quality unit to ensure that all critical deviations are investigated and resolved.
  • Failure to properly maintain buildings used in the manufacture of API in a clean condition.
  • Failure to prevent unauthorized access or changes to data, and to provide adequate controls to prevent manipulation and omission of data.


For a view of a variety of letters related to manufacturing quality, see the Office of Manufacturing Quality section of FDA’s website.

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