FDA Warning Letters Week of 1/5/2020: Data Discrepancies and Process Validation

Among FDA-posted warning letters this week, the Center for Tobacco Products posted four warning letters, one GMP drug warning letter from CDER and yet another, the 4th, warning letter regarding failure to comply with the Foreign [Food] Supplier Verification Program (FSVP) posted this week.  Two warning letters regarding FSVP compliance were posted last year, and two have already been posted this year.  We cover the warning letter from CDER below.

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DRUG | Apollo Health And Beauty Care

Apollo Health And Beauty Care (Ontario, Canada) received a warning letter from CDER on December 23, 2019 based on the outcome of an inspection ending August 16, 2019.  The firm is a contract manufacturer for OTC drug products.  FDA recommends that the firm hire a qualified consultant to assist them in coming into GMP compliance.  They were placed on import alert 66-40 on December 16, 2019.  

While the early FDA findings of problematic and questionable data were in the laboratory, investigators are more frequently evaluating electronic records in the manufacturing area and comparing these data with data in, for example, paper batch records.  This inspection is NOT the first time that HMI data have been reviewed along with paper batch records, but it’s a great example to reinforce that all electronic records are subject to FDA evaluation and comparison with paper records of the same data.

  • The investigator identified data discrepancies between the Human Machine Interface (HMI) and the batch record.  Data were recorded in the batch record at a time when the HMI was determined not to be operational.  For remediation, the firm stated they would randomly select batch records and compare the data and investigate any discrepancies.  The FDA did not approve of this approach because it would not “…fully evaluate the scope of the discrepancies…or practices of operators not following batch instructions.”   Further, “Your quality system does not adequately ensure the accuracy and integrity of the data to support the safety, effectiveness and quality of the drugs you manufacture.  Without complete and accurate records, you cannot assure appropriate decisions regarding batch release, product stability, and other matters that are fundamental to ongoing assurance of quality.”
  • The firm did not have complete process validation.  This is a repeat observation from an inspection in December 2019.  The lengthy hold time of bulk prior to filling of drug products is not validated.  Operators fail to follow batch records or document deviations so that they can be investigated.
  • The firm failed to perform adequate investigations in a variety of areas including particles in lots of drug product and management of OOS test results For the lot(s) with particles, only a portion of the lot was rejected.  Similarly, for the OOS result found at the beginning of the filling process, the cause was assigned to residual rinse water contamination at the beginning of the fill, however, there was no documentation to support this.  The later portions of the lot were released but there was no documentation to support this.  Inadequate investigations were also cited in the December 2016 inspection.


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