Chinese API supplier lands in hot water with FDA
- The Food and Drug Administration sharply criticized Chinese drug supplier Suzhou Pharmaceutical Technology Co. in a recently posted warning letter, the first such notice to be issued for manufacturing violations so far this year.
- While FDA warning letters citing manufacturing shortcomings have become common, Suzhou was particularly brazen in its missteps. Notably, Suzhou had no quality control unit and sales staff routinely signed off on certificates as "QC Director," according to a June inspection.
- After judging Suzhou's response to be insufficient, the FDA placed the active pharmaceutical ingredient (API) maker on its import ban list last October.
In addition to lacking a quality unit, Suzhou also shipped to the U.S. API manufactured by a supplier previously banned from exporting to the U.S. The company claimed it was the manufacturer of the API in question when it shipped the banned API.
Passing goods off as its own appears to be standard procedure for Suzhou, at least before the FDA issued its findings. According to the warning letter, Suzhou would copy and paste manufacturing data from original suppliers onto its own letterhead and pass it off as a certificate of analysis.
In its letter, the FDA recommended Suzhou hire an outside CGMP consultant to help the firm get back into compliance with regulatory standards. Until that time, the regulator can refuse entry to any products made by Suzhou at the deficient facility as well as withhold approval for any product submitted.
While Suzhou is the first Chinese supplier to be flagged for GMP flaws this year, the FDA warned 15 other companies for GMP deficiencies last year — part of a trend of stepped-up enforcement in one of the largest markets for API manufacturing.
The regulator also posted a warning letter sent to the Japanese company Sato Yakuhin Kogyo Co., which failed to maintain appropriate data controls and mishandled batch testing.
- FDA Warning letter
- BioPharma Dive FDA to drugmakers: Don't let manufacturing lead to rejection
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