FDA posted six new warning letters this week including one to a compounding pharmacy and two to finished drug manufacturers. Both finished drug manufacturers are located outside the US. We address those below.
Finished Drug Manufacturers:
- Zhejiang Ludao Technology Co., Ltd (Taizhou, China) received a warning letter on February 23th 2018 based on the outcome of an inspection ending August 18th 2017. The firm manufactures OTC drug products. FDA placed the firm on Import Alert 66-40 on December 28th 2017. FDA recommends that the firm hire a qualified GMP consultant(s) to assist in complying with CGMPs. The firm also received the fully detailed 3-part boilerplate request for information regarding data integrity remediation. Deficiencies include but are not limited to:
- The firm prepared Certificates of Analysis for batches of drug product that were not yet manufactured. The firm also acknowledged that they falsified analytical results of product released for sale in the US.
- Investigators found data in the electronic recycle bin of a stand-alone HPLC system. The instrument also lacked audit trail capability and back-up, so the extent of data deletion could not be determined.
- The firm did not test incoming raw materials including APIs to ensure they met acceptance criteria. The firm has also not verified the reliability of their vendors CoA data.
- For at least one product, the firm failed to test for assay and microbial attributes during stability evaluation.
- Nan San (HK) Pharmaceutical Factory Limited (Kowloon, Hong Kong) received a warning letter on February 23th 2018 based on the outcome of an inspection ending September 29th 2017. The firm was placed on Import Alert 66-40 on January 8th 2018. The firm manufactures OTC products. FDA also identified misbranding issues for this firm. FDA encourages the firm to hire a qualified consultant to assist them in coming into compliance with CMPs. GMP deficiencies include but are not limited to:
- The firm did not test final products before release. Further microbial limit testing was performed on one batch in 2013 and this result was reported on subsequent batches released to the US market.
- The firm employs a contract testing lab and this lab does not test for the multiple active ingredients in a product prior to release of the final drugs.
- The firm did not validate the manufacturing process, nor do they have an ongoing program for monitoring in-process controls.
- The firm does not test incoming APIs and other components prior to use in manufacturing.
- The firm does not have adequate stability data to support the labeled expiry date.
- Snyder Mark Drugs Roselle, Inc d.b.a. Mark Drugs Pharmacy (Roselle IL) received a warning letter on February 27th 2018 based on the outcome of an inspection ending on May 22th 2017. FDA identified six examples of where the firm manufactured sterile drugs under “insanitary conditions.” Further, they identify six areas where the firm fails to comply with 21CFR211. The firm was also cited for commercializing unapproved new drugs and misbranded drugs.
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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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