Week of September 23rd 2018 | FDA Sent These Warning Letters to Pharma Companies

FDA posted 6 warning letters on the website this week including:

  • 1 letter issued to a compounding pharmacy
  • 1 issued to a finished drug facility


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  • Wilson Medicine Company (India) received a warning letter on September 11th 2018 based on the outcome of an inspection ending March 1st 2018. The firm manufactures OTC drugs. FDA suggests they employ consultant(s) to help them come into GMP compliance. Deficiencies include but are not limited to:
    • The firm did not conduct either equipment qualification or process performance qualification. FDA asks the firm: In response to this letter, provide your validation and equipment qualification protocols, and reports with timelines for completion for all drug products distributed to the U.S. market. Also include a detailed summary of your approach for routinely monitoring intra- and inter-batch variation to ensure an ongoing state of control.”
    • Analytical tests used in release testing are not validated (or qualified if USP tests). In response to this letter, FDA asks the firm to provide:
      • An independent assessment of all test methods used by your firm to ensure they have appropriate instructions, method suitability criteria, and appropriate validation (or verification, for USP compendial methods) to determine whether they are fit for purpose.
      • Your plan of action to complete validation (or verification, for USP compendial methods) for all analytical test methods used in association with products shipped to the United States.
      • A comprehensive independent review of your entire laboratory system, and a corrective action and preventive action (CAPA) plan that ensures full remediation of the laboratory operation. For example, the review of your laboratory system should include, but not be limited to, the suitability of all laboratory equipment, a fully remediated calibration program, staff competencies, supervisory oversight, data systems, and other elements of laboratory control.
      • A summary of test results obtained from testing retain samples of all drug products within expiry. You should test all appropriate quality attributes including, but not limited to, identity, strength, and purity of active ingredients and finished drug products. If your testing for any previously released batch yields any out-of-specification results, indicate the corrective actions you will take, including notifying customers and initiating recalls.”
    • The firm did not conduct cleaning validation for non-dedicated equipmentIn response to this letter, FDA asks the firm to provide:
      • “Your updated cleaning validation protocol and subsequent report for all equipment used in the manufacture of your drugs, including results to show whether results meet established acceptance criteria. Also include updated procedures for equipment cleaning and maintenance, and details on how you will effectively train employees.
      • A risk assessment to determine the effect of inadequate cleaning practices on product quality for drug products within expiry and distributed to the U.S. market.
      • Your proposed market action plan, which may include customer notifications, additional testing, and enhanced complaint monitoring for drug products within expiry and distributed to the U.S. market at risk for potential cross-contamination.
      • Your plan of action for ensuring adequate cleaning in the interim, before completing your planned validation studies, including, but not limited to, cleaning verification sampling with appropriate acceptance criteria.
      • A comprehensive, independent review of your facility to identify factors that present potential risks of cross-contamination of products manufactured at your facility. Include an assessment of the suitability of your facility design to prevent cross-contamination, with an evaluation of your equipment, materials, personnel, and waste flows. Include a detailed CAPA plan with systemic remediation and timelines of improvements to your cross-contamination control strategy.”


  • Pharmacy Doctors Enterprises (dba Zion Clinical Pharmacy) (Hallandale Beach, FL) received an untitled letter on August 17th 2018 based on the outcome of an inspection ending November 20th 2017.
  • Atlas Pharmaceuticals, LLC (Phoenix, AZ) received a warning letter on September 11th 2018 based on the outcome of an inspection ending September 26th 2017 (yes, a year later).


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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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