Chinese/Indian manufacturing facilities facing repercussions
- The Food and Drug Administration is coming down hard on several companies that have committed violations that lead to censure and being banned from importing pharmaceutical products into the U.S., the Regulatory Affairs Professional Society reported. The companies in question include Concept Products Ltd. in China and Laxachem Organics and Artemis Biotech in India.
- Concept Products Ltd., based in TIanjan, failed to commit to any corrective actions after an FDA inspection last summer, according to a warning letter the FDA sent the company last month.
- Meanwhile, managers at Laxachem Organics' Amravati site refused entry to inspectors, and German regulators found 35 deficiencies at an Artemis Biotech facility.
It's one thing to undergo an inspection, find out that your plant is in violation, vow to take corrective action---and then follow through. It's another thing entirely to undergo an FDA inspection, be cited for numerous major violations and then fail to take action. In the former case, the FDA is generally willing to work with a company or individual facility, however, in the latter case, all bets are off.
That's the case with Concept Products Ltd., which has deficiencies in the areas of batch-product testing, protocol around written procedures and cleaning and maintenance of equipment. And as a result, the FDA told Concept Products Ltd. that until the violations are addressed, the FDA has the right to refuse import of any product containing any ingredient manufactured by the company.
For Artemis, some of the violations included conducting repackaging operations without documentation and quality assurance oversight and inadequate control of labeling processes among other things.
The FDA has no plans to ease off of its increasingly aggressive inspection practices in China, India and elsewhere. The agency does, however, provide some advice to companies that are in violation. As the agency told Concept Products in its warning letter:
"If your firm resumes manufacturing drugs for the United States market, we strongly recommend engaging a consultant, qualified as set forth in 21 CFR 211.34, to assist your firm in meeting CGMP requirements. Using a consultant does not relieve your firm’s obligation to comply with CGMP."
- Regulatory Affairs Professional Society Chinese and Indian Firms Warned and Banned by US FDA and German Competent Authority