Are your complaint investigations adequate?

complaint investigations

Do you have sufficient information in your complaint investigations?  Do your investigation reports include conclusions and follow up?

A company was recently cited for:

… Written records of investigations into unexplained discrepancies and failures of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.

Your investigations are inadequate for reasons including but not necessarily limited to root cause evaluation, corrective and preventative actions and the performance of an investigation.

Specifically, you discovered a candy wrapper in your ISO 5 aseptic processing equipment located in room … Your investigation states operators were notified of this event and that food and drink are prohibited in the aseptic processing rooms. However, your investigation lacks documented operator interviews and any documented corrective or preventive action even after you indicate aseptic gowning and/or aseptic technique as a potential root cause. Your investigation states both that this event is low risk and that it is classified as a critical deviation. You processed …, lot … immediately before discovering this candy wrapper.

According to the Code of Federal Regulations, 21 CFR 211.198, complaint investigations must have the following information:

  • The written record shall include the following information, where known: the name and strength of the drug product, lot number, name of complainant, nature of complaint, and reply to complainant.
  • The written record shall include the findings of the investigation and follow-up. The record or copy of the record of the investigation shall be maintained at the establishment where the investigation occurred
  • If an investigation is not conducted, the written record shall include the reason that an investigation was found not to be necessary and the name of the responsible person making such a determination.

For information on medical device complaints and investigations, see 21 CFR 820.198 Complaint files and FDA Presentation Complaint Files.

To view more observations pertaining to drug complaints, refer to the following GMP Trends® Issues:  1086, 1084, 1082, and 1074.  To view more observations pertaining to medical device complaints, refer to the following GMP Trends® Issues:  1085, 1084, 1075, and 1073.

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