This week there were three warning letters, all for drug GMP failures. Each company was placed on import alert.

  • DRUGS: Hangzhou Zhongbo Industrial Co., Ltd. (Zhejiang, China) received a warning letter on November 27, 2018 based on the outcome of an inspection ending April 27, 2018. The firm is yet another OTC manufacturer to receive a warning letter. They also use a contract laboratory. FDA states that their “…quality unit is not able to fully exercise its authority and/or responsibilities.” The warning letter also identified repeat observations from the July 2016 inspection. They were placed on import alert on September 28, 2018. Deficiencies include but are not limited to:
    • Product is released without conducting testing on finished product. The results from one batch appear to be used to release others.
    • Expiry dating is not supported by long term stability testing. The result of accelerated testing is used as the basis for expiry dating. The company says their contract laboratory is responsible to determine the stability program for their products. As expected, FDA reminds them they are responsible for their product quality regardless of any agreements made with contract service providers.
    • The firm failed to test incoming raw materials. The results of the suppliers CoA are accepted.
  • DRUGS: Soleo (Republic of South Korea) received a warning letter on December 13, 2018 based on the outcome of an inspection ending August 9, 2018. The warning letter also notes that one of their products is an unapproved new drug. This is another OTC manufacturer. The firm was placed on import alert on November 26, 2018. GMP deficiencies include but are not limited to:
    • Incoming raw materials, including active ingredients, were not tested but rather the firm relied on the vendor CoA.
    • Tests used to evaluate active ingredients before distribution are not validated.
    • The firm has not validated the manufacturing process for the OTC drug product which contains four active ingredients, nor did they qualify the manufacturing equipment.
    • There is no stability data to support expiry dating.
  • DRUGS: Longbow First Aid Products Manufactory (Foshan, China) received a warning letter on December 14, 2018 based on the outcome of an inspection ending April 20, 2018. The firm also manufactures OTC products. The firm was placed on import alert on August 17, 2018. FDA recommends the firm employ qualified consultant(s) to assist them in coming into compliance with GMPs. The firm also functions as a contract manufacturer. Deficiencies include but are not limited to:
    • The firm released products to market without testing. The firm released multiple batches of ‘purportedly sterile’ products without conducting sterility testing. The firm said they did not conduct sterility testing because it was not a customer requirement.
    • The firm did not demonstrate that their aseptic processing, including sterilization, can prevent microbial contamination of the ophthalmic products. This included lack of adequate equipment sterilization, and lack of media fill studies.
    • The firm failed to test incoming raw materials but rather relied on the vendor CoA from unqualified suppliers.
    • The firm does not have an established stability program and thus cannot demonstrate stability of the product through the labeled expiry period.

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. | | 805.217.9360