Now that the government shutdown is over, at least for 3 weeks, FDA has started publishing warning letters. We have two from this week: one to a finished pharmaceuticals manufacturer, and one to a manufacturer of human cells, tissues, and cellular products.
- DRUGS: Hangzhou Guoquang Touring Commodity Co. Ltd. (Zhejiang, China) received a warning letter on December 14, 2018 based on the outcome of an inspection ending April 20, 2018. The firm manufactures OTC products and is also a contract manufacturer. FDA reminds them they are responsible for the quality of drugs they produce under contract regardless of agreements that may be in place with their customers. FDA recommends the firm hire consultant(s) who can help them come into compliance with CGMPs. Further, FDA placed them on import alert on October 5, 2018. Deficiencies include but are not limited to:
- The firm has not conducted cleaning validation for non-dedicated equipment. These equipment are also used to manufacture nondrug products, names were redacted.
- The firm released product, some with failing test results, prior to review by the quality unit.
- The firm’s final product testing does not include tests to determine whether specifications are met including identity, strength, purity, and quality of the active ingredient and tests for objectionable organisms.
- The stability program is inadequate because it does not include evaluation of assay determination of the active ingredient.
- DRUGS: The University of Miami Reproductive and Fertility Center (Miami, FL) received a warning letter on December 3, 2018 based on the outcome of an inspection ending July 12, 2018. Overall the deficiencies address shortcomings in screening for infectious diseases. The firm must comply with 21 CFR 1271. Deficiencies include but are not limited to:
- Failure to determine ineligible a donor who has a risk factor for or clinical evidence of a communicable disease. At issue is the risk for Zika Virus in Miami Dade County.
- Labeling for the HTC/P does not include the Biohazard legend.
- Failure to screen a donor for a variety of infectious diseases including Zika, syphilis and West Nile Virus.
- Failure to document that a donor was ‘eligible’ including the results of infectious disease tests and questionnaires.
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About the Author
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.
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