FDA Warning Letters Week Of 9/6/2020: Data Integrity Failures & Lack of Cleaning Validation

Last week, FDA issued issued two Warning Letters to pharma companies for GMP violations. One cited data integrity failures among other observations at an OTC manufacturer while the second cited a drug repackager for cleaning validation issues.

Interestingly, cleaning validation (or lack thereof) was a focus of one of the previous week’s Warning Letters.

Details are covered below.

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Drug Warning and Untitled Letters

PT. MegaSurya Mas

PT. MegaSurya Mas (Indonesia) received a Warning Letter on August 24, 2020 based on the outcome of an inspection ending November 15, 2019. The firm manufactures OTC drug products.  FDA recommends the firm hire qualified consultants to assist them in coming into compliance with GMPS. FDA also states “Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs.” The firm was placed on Import Alert 66-40 on June 18, 2020. Deficiencies include but are not limited to:

  • Failure to conduct adequate testing prior to distribution of product. The firm admitted that a batch release document dated August 14, 2019 had at least one test shown conducted in November 2019. FDA states This discrepancy on batch release documents demonstrates a concern regarding the validity in your CGMP records.” Further, the analytical test methods were not adequately validated. FDA deemed the firm’s response inadequate because it did not address the failure to perform adequate release testing.  
  • The firm failed to test incoming APIs but rather released them on review of the Certificate of Analysis. The reliability of the CoA data was not established, nor was an identity test conducted. 
  • Manufacturing processes were not validated, nor the cleaning system, and—I’m guessing here—the water system. The firm’s response was inadequate because they did not provide sufficient information to FDA including a timeline for completion. In addition, they did not address the impact of this failure on products already in U.S. distribution. 
  • The Quality unit failed to exercise its responsibility. FDA provided numerous areas of failure including but not limited to the failure to establish master batch records, oversee lab controls for computerized systems, evaluate discrepancies, and Out-of-Specification results. 
  • The stability program is inadequate. No procedures or protocols for either accelerated or long term testing were available.

Calvin Scott & Company, Inc.

Calvin Scott & Company, Inc. (Albuquerque, NM)  received a Warning Letter on August 25, 2020 based on the outcome of an inspection ending March 12, 2020. The warning letter went to the CEO located in Newport Beach, CA. The firm repackages drug products. FDA also recommends the firm employ a qualified consultant to ensure they come into GMP compliance. Deficiencies include but are not limited to:

  • The firm does not have stability data to support the expiry assigned to the repackaged drug products. Further, the new container does not meet the requirement that the drug be dispensed “in tight, light-resistant container as defined in the USP.”  
  • The firm lacked cleaning validation for surfaces that shared product contact among different products. 
  • The firm does not have a quality unit. These responsibilities are divided among various functions.

Device Warning and Untitled Letters

There were none this week.

BIMO, GCP and GLP Warning and Untitled Letters

There were none this week.

Compounding Pharmacy / Outsourcing Facilities

There were none this week.

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