Week of June 3rd, 2019 | FDA Sent These Warning Letters to Pharma/Device Companies

It was a slow week for warning letters with just two new published.  Both were issued to drug manufacturers.


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DRUGS | Kingston Pharma LLC

Kingston Pharma LLC (Massena, NY) received a warning letter based on the outcome of an inspection ending December 10, 2018.  The firm manufactures over-the-counter (OTC) drugs.

FDA recommends the firm hire consultants to assist them in meeting FDA requirements.  The warning letter also identifies misbranding violations.

Deficiencies include but are not limited to:

  • The Quality Unit released four batches prior to completion of analytical testing.  The firm admitted this and said they were released “on a risk basis while awaiting results.”
  • Manufacturing processes were not validated.  In addition, the firm failed to qualify equipment used to manufacture drug product.
  • Data to support a two-year expiry date are not available.
  • Facilities are not maintained in a state of good repair.

DRUGS | Pharmasol Corporation

Pharmasol Corporation (Easton, MA) received a warning letter dated March 14, 2019 based on the outcome of an inspection ending August 20, 2018.

The firm appears to be a contract manufacturer of drug product.  FDA recommends the firm hire qualified consultants.  Many of these same deficiencies were identified in previous inspections.

Deficiencies include but are not limited to:

  • One of the firm’s clients reported leaking stability units for three validation lots that were subsequently ejected.  Container closures were changed, validation repeated and the leaks continued.  Interestingly, “In your response, you suggested that the leaking did not compromise the quality of the drug product.  You proposed to stop placing stability samples in a horizontal position, adding “upward arrows” to the shipping cartons, evaluating shipping containers for the necessity of additional dividers, and providing shipper instructions to ‘keep product upright.’  Your response was inadequate in that you did not identify a root cause or suggest a corrective action for the leakage.”
  • The firm lacks Quality Unit oversight.  More than 40 deviations were open beyond the due date.  These addressed significant quality issues such as leaking containers, deviation from key production parameters and OOS solvent assays for product release testing. “During our inspection, you explained that you believed that lapses in quality system performance were due to the strained quality system, your firm’s cumbersome procedures, and inefficient management of resources.”  The firm was also cited in 2015 for similar Quality Unit Failures.
  • Stability samples were not tested within the time frame called for by procedure.  An 18-month sample was not tested until 254 days after the sample was received in the laboratory. Deficiencies were also identified in the 2014 and 2015 FDA inspections.
  • The investigator found discarded worksheets in a recycling bin;  they indicated OOS results for measurement of incoming containers and caps.

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About the Author

Barbara W. Unger is Govzilla’s Quality Expert and Editor-in-Chief of GMP Regulatory Intelligence. She formed Unger Consulting, Inc. in December 2014 to provide GMP Quality consulting services to the pharmaceutical and biopharmaceutical industry. At Amgen, she led the segment of the Corporate GMP Audit group at Amgen focused on API manufacturers, Quality Systems and Computers. She developed, implemented and maintained the GMP Regulatory Intelligence program for 8 years at Amgen Inc. This included surveillance, analysis and communication of GMP related legislation, regulations, guidance and industry compliance enforcement trends. This was an essential service and tool within the Corporate Audit function.  Unger Consulting Inc. | www.ungerconsulting.net | 805.217.9360

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