FDA Warns Three International Drugmakers
The US Food and Drug Administration (FDA) on Tuesday released three warning letters sent this month to drugmakers in India, China and South Korea detailing good manufacturing practice (GMP) violations observed at the companies' facilities.
Alchymars
In its warning letter to Tamil Nadu, India-based active pharmaceutical ingredient (API) manufacturer Alchymars ICM SM Private Limited, FDA cites the company for having inadequate facilities for equipment and personnel cleaning, data integrity issues and failing to adequately investigate customer complaints following a five-day inspection in September 2017.
"The equipment washroom … was found in a filthy condition with damaged tiles and standing water [and] the handwashing stations intended for the class-100,000 (ISO-8) areas in sections [redacted] and [redacted] of your facility were visibly dirty," FDA writes.
And FDA says the handwashing stations did not have hot water, soap or hand drying equipment, a repeat issue from a 2015 inspection of the facility.
FDA also says Alchymars falsified laboratory data for water point-of-use tests.
"For multiple points of use, your analyst reported far fewer [colony-forming units] CFU than observed on the plate by our investigator," FDA writes.
According to the warning letter, Alchymars suspended production of certain API based on a risk assessment related to the falsified test results, and FDA says the company must notify the agency before resuming production of those APIs for US distribution.
Additionally, FDA says the company failed to thoroughly investigate complaints of "black spots" in a finished API.
"You did not perform a detailed review of production records or equipment cleaning and maintenance logs, even though equipment gaskets were found to be the root cause of similar past complaints," FDA writes.
Shanghai Weierya
FDA also issued a warning letter to Shanghai Weierya Daily Chemicals Factory following an inspection of its Shanghai, China facility last April that resulted in the company being placed on import alert in September.
According to the warning letter, Shanghai Weierya released batches of an over-the-counter (OTC) drug "without adequate testing for total count and objectionable microorganisms." FDA also notes that the company's procedures only call for testing one lot every six months, which is inadequate for ensuring that all batches conform to specification before release.
Additionally, FDA says the company failed to test components and excipients from other suppliers to ensure their identity prior to use.
Newcos Co.
FDA also issued a warning letter to Seoul, South Korea-based drugmaker Nowcos Co., Ltd. for failing to validate manufacturing processes, test methods and cleaning procedures following an inspection in July and August.
Based on FDA's observations during the inspection, the agency placed the company on import alert last December.
"You did not perform process qualification studies. You also lack an ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality," FDA writes.
FDA also says the stability studies Newcos conducted did not ensure that its OTC products will remain within specification through their labeled expiration date.
Warning Letters: Alchymars, Shanghai Weierya, Newcos