Week of October 6th, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

E-cigarette vaping supplies are almost the sole topic of warning letters posted this week.  It seems that FDA is playing catch-up after largely ignoring enforcement in this area.  In the areas we cover, there was only one posted warning letter to a fertility clinic, but we also cover two announced warning letters that FDA has not yet published.

 

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A warning letter to watch for, Glenmark (India) announced that FDA issued a warning letter to the Baddi facility in Himichal Pradesh, India.  The most likely inspection associated with this warning letter is one that ended April 20, 2019 and resulted in an 11-page form 483.  The products in question are topical ointments/creams manufactured at the site.  Justin Boyd was one of the two investigators.  The form 483 cites inadequate investigations into customer complaints and provides almost 5 pages of examples.  After the inspection, the firm recalled product from the US market that had been subject to “temperature abuse.”  The firm had at least two recalls for product made at this site.

The Torrent Pharmaceuticals plant in Gujarat announced they received a warning letter this week based on an inspection in April 2019 conducted by three FDA investigators.  The Company notified the BSE according to stock exchange listing requirements.  This plant manufactures both finished drug product and APIs.  The form 483 that precipitated this warning letter is 17 pages long and identifies one observation for API production and three observations for drug product manufacture.  The first observation addresses management of OOS events and provides 10 (yes, 10) pages of examples of shortcomings in this area.  Front and center is the exceptional number of OOS events where results were invalidated (73% for finished product and 61% for stability between January 2017 and March  2019), in addition to identify root cause for OOS events and implementation of effective corrective actions.  Additional observations were identified in the area of process validation where batches failed to meet protocol requirements and quality attributes but nonetheless were considered successful process validation batches and inadequate calibration and preventive maintenance of key pieces of equipment.  The sole observation for API production is inadequate management of OOS events though this did not include the number of examples as FDA provided for the finished product manufacture observation on the same topic.  A second site in Dahej, India also had an inspection in March and it has an OAI classification.  The form 483 issued to this site is 7 pages long with 5 observations in the areas of:

  • OOS investigations which was identified as a repeat observation from a 2017 inspection;
  • shredding of original GMP documents, some with the notation that “previous data needs to be shredded”;
  • records were not retained for the required period after product expiry;
  • lack of investigations into unexplained discrepancies and the failure to include conclusions and follow up.

HUMAN CELLS/TISSUES | Family Fertility Center

Family Fertility Center (Houston, TX) received a warning letter on September 30, 2019 based on the outcome of an inspection ending June 26, 2019.

The warning letter identifies four deficiencies, all associated with testing of donors and documentation of those results.  This is a common set of deficiencies for firms that provide human cells or therapies, they cannot seem to get the donor testing and documentation correct.  FDA notes that the donor eligibility determinations for existing inventory of eggs, oocytes and embryos are incomplete and the items must remain in quarantine.  The firm must request an exemption in order to remove these items from quarantine or to ship them to another establishment consistent with the requirements of 21 CFR1271.155.

Deficiencies include but are not limited to:

  • Failure to review the donors’ medical records for risk factors and clinical evidence of communicable disease.
  • The responsible person failed to determine and document the eligibility of the tissue donor.
  • Donors with high-risk factors were not determined to be ineligible, or subject to additional screening.
  • Procedures describing all steps in the donor eligibility process were not established and maintained.

 

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