ADVERTISEMENT
2 /3 FREE ARTICLES LEFT THIS MONTH Remaining
Chemistry matters. Join us to get the news you need.

If you have an ACS member number, please enter it here so we can link this account to your membership. (optional)

ACS values your privacy. By submitting your information, you are gaining access to C&EN and subscribing to our weekly newsletter. We use the information you provide to make your reading experience better, and we will never sell your data to third party members.

ENJOY UNLIMITED ACCES TO C&EN

Pharmaceuticals

FDA Faults Three Ipca Drug Plants

by Jean-François Tremblay
February 22, 2016 | APPEARED IN VOLUME 94, ISSUE 8

The U.S. Food & Drug Administration issued a warning letter to India’s Ipca Laboratories after U.S. inspectors discovered that the drug company breached manufacturing regulations at three of its plants. The letter insinuates that Ipca’s management was aware of, and even encouraged, noncompliance. For instance, during the inspection of Ipca’s Ratlam facility, a quality lab employee told an FDA inspector that “if we find a failure, we set back the date/time setting and reintegrate to achieve passing results.” FDA inspectors also found “multiple examples of [Ipca’s] practice of back dating and falsifying laboratory data.” Ipca will not be able to introduce new drugs to the U.S., and Ipca products that are currently authorized for U.S. sale may be banned, the letter says.

X

Article:

This article has been sent to the following recipient:

Leave A Comment

*Required to comment