FDA posted 15 warning letters this week — many issued by the Center for Tobacco Products, and 3 issued for firms in the areas we cover.
- GLP STUDIES, BIMO: Benedict S. Kiao, MD, at the Oeyama-Moto Medical Group Foundation, Inc (West Covina, CA) received a warning letter dated May 21st 2018, based on the outcome of an inspection conducted by four investigators ending August 11th 2017. I think the attitude of the letter recipient can be summed up in the quote in the second bullet point. Deficiencies include but are not limited to:
- There was not a Quality Unit available to oversee all studies and records.
- The firm did not have basic SOPs necessary for GLP studies including those on animal room preparation, receipt, identification, storage, handling, mixing, a method of sampling of the test, and control others to name a few. “During the inspection, you indicated that as a surgeon, you knew all operation procedures, and therefore you did not agree that SOPs needed to be established.” That approach didn’t meet with FDA’s approval!
- Study data were not accurately recorded and verified.
- Raw data were not stored or retained for retrieval. The absence of raw data is a serious omission.
- The firm did not conduct tests using appropriate analytical methods.
- Study protocols did not include sufficient detail.
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- Biologique Recherche (B.R.) SAS (Suresnes, France) received a warning letter on June 8th 2018 based on the outcome of an inspection ending September 22nd 2017. The firm manufactures OTC products. The firm was placed on Import Alert 66-40 on January 17th 2018. FDA also suggests the firm employ a qualified consultant to assist them in coming into GMP compliance. Deficiencies include but are not limited to:
- The Quality Unit was not able to fully exercise their authority and responsibilities.
- The firm released products without testing for the identity and strength of active ingredients. FDA asks the firm to provide:
- “All chemical and microbial test methods and specifications used to analyze each of your OTC drug products prior to a batch disposition decision;
- remediated microbiological testing methods (i.e., total counts and objectionable microbes) that conform to USP <61> and <62>. These methods should be capable of identifying all microorganisms in product bioburden to determine whether any are objectionable in view of the product’s intended use.
- a summary of test results obtained from testing retain samples of all OTC drug products within expiry that have been distributed in the United States. These test results should include identity and strength of active ingredients, and all other appropriate quality attributes.”
- The firm did not test incoming raw materials but rather relied on the vendor’s certificate of analysis. In response to the warning letter, FDA asks the firm to provide:
- “Quality control release specifications for all incoming components, and the tests you perform for each lot;
- a summary of test results obtained from full testing of all your incoming components to validate the COA from each raw material manufacturer;
- a summary of your procedures for qualifying and overseeing the adequacy of contract facilities that test the OTC drug products you manufacture;
- a comprehensive, independent review of your material system to determine whether all containers, closures, and ingredients from each supplier are adequately qualified, assigned appropriate expiration or retest dates, and incoming material lot controls are adequate to prevent use of unsuitable containers, closures, and components.”
- The firm is missing basic SOPs for GMP operations.
- The firm does not have stability data to demonstrate chemical and microbiological stability thru expiry.
- The firm has not validated the drug manufacturing processes.
- Moore’s Pharmacy Inc (Sinton, TX) received a warning letter on January 1st 2018 based on the outcome of an inspection ending September 1st 2016.
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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.
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