Week of Mar 25th 2018 | FDA Sent These Warning Letters to Pharma Companies

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Week of Mar 25th 2018 | FDA Sent These Warning Letters to Pharma Companies

By | 2018-04-06T12:25:29+00:00 April 6th, 2018|Biopharma / Pharma, FDA Enforcement Trends, FDA Warning Letters|

FDA posted 8 warning letters this week, including:

  • 1 API manufacturer
  • 1 finished dosage form manufacturer
  • 2 compounding pharmacies

DRUGS

  • Keshiva Organics Pvt. Ltd (Maharashtra, India) received a warning letter dated March 15th 2018 based on the outcome of an inspection ending May 31st 2017. The firm is an API manufacturer. FDA identifies that inspections in 2011 and 2014 identified similar CGMP deficiencies. They also suggest that the firm employ a qualified consultant(s) to assist them coming into GMP compliance. Deficiencies include but are not limited to:
    • Management of OOS events is deficient. OOS results were disregarded based on a successful retest, although there was not a Phase I investigation to investigate the OOS event. Further, they did not conduct Phase 2 investigations to identify root cause. In response to this, FDA instructs the firm to provide the following:
      • “A retrospective review of all invalidated OOS (in-process and finished testing) results obtained for products on the U.S. market. Assess whether the scientific justification and evidence was conclusive. For investigations that conclusively establish laboratory root cause, determine adequacy of the CAPA, and ensure that other laboratory methods vulnerable to the same root cause are identified for remediation. For any OOS with inconclusive or no root cause identified in the laboratory, include a thorough review of production (e.g., batch manufacturing records, adequacy of the manufacturing steps, raw materials, process capability, deviation history, batch failure history). Provide a CAPA plan that identifies the potential manufacturing root causes for each such investigation and includes process improvements where appropriate.  
      • An independent assessment of your system for investigating OOS results. Include a CAPA to remediate OOS investigations at your facility. Elements of your CAPA should include, but not be limited to, immediate laboratory investigation of OOS results, enhanced quality assurance participation in investigations, identification of adverse laboratory control trends, and proper initiation of the Phase 2 manufacturing quality investigation stage.
      • An independent assessment and CAPA of your overall investigation systems, including: investigating deviations, atypical events, OOS results, complaints, and failures. The CAPA should include but not be limited to, enhanced investigation competencies, improved procedures, and substantial improvements in quality unit oversight of investigations.”
    • The firm does not maintain complete laboratory data for product distributed in the US. Data sheets did not include sample weights, batch/lot number for reference standards and reagents, equipment identification, and complete TLC data. FDA instructs the firm to provide the following:
      • “Provide a comprehensive investigation into the inadequacies in data, records, and reporting. Identify omissions, alterations, deletions, record destruction, non-contemporaneous record completion, and other deficiencies. In addition, describe all parts of your facility’s operations in which CGMP information is not recorded and maintained. Include a CAPA to remediate data recording and record retention practices throughout your operation.
      • Provide a risk assessment summarizing the effect of incomplete data on assessing laboratory control and product quality.
      • Provide a comprehensive corrective action plan, with a target date, to ensure that laboratory records are complete.”

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  • Clover Custom Blending LLC (Tampa, FL) received a warning letter on February 28th 2018 based on the outcome of an inspection ending May 17th 2017.  FDA addresses OTC drug products in the body of the warning letter. FDA recommends the firm hire qualified GMP consultant(s) to assist in coming into GMP compliance. Note that the first deficiency was based on data from their contract laboratory. Deficiencies include but are not limited to:
    • The results generated by their contract laboratory for the 3 active ingredients in the firm’s sun screen product were OOS, resulting in super-potency. The firm released the batch. They explained that they felt the OOS event was due to a laboratory error at the contract laboratory and did not initiate an OOS investigation.
    • The firm is missing key GMP procedures including those for training, completion of MBRs, recalls, complaints, and deviations.
    • The firm shares equipment with non-pharmaceutical, industrial grade products with those used in manufacturing of OTC products. There were no cleaning procedures or documentation for this shared equipment. Further, a mixer motor was observed to be covered in flaking paint. FDA states the firm should “discontinue manufacturing drugs on shared equipment in your facility.”  
    • Incoming components of OTC sunscreen products are not tested for identity at a minimum.
    • FDA also identifies issues of misbranding drug products.

COMPOUNDING PHARMACIES:

  • Medaus, Inc (Birmingham, AL) received a warning letter on March 8th 2018 based on the outcome of an inspection ending March 11th 2016 (no, that’s not a typographical error). The firm recalled all sterile drug products within expiry based on lack of sterility assurance in response to an FDA requested recall letter dated May 3th 2016.
  • Pharmacy Resources Incorporated (Denver, CO) received a warning letter on March 1st 2018 based on the outcome of an inspection ending May 23rd 2017. The letter identifies 7 GMP deficiencies and identifies misbranding of some drugs.

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About the Author

Barbara W. Unger

Barbara W. Unger 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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