There's another FDA manufacturing crackdown in the works. This time it's a Sun Pharmaceutical's U.S. unit that's fallen down in the agency's eyes. Inspectors discovered manufacturing violations at a plant in Cranbury, NJ, during visits from February through April; the company's proposed fixes, submitted to the agency in May, weren't "sufficient corrective actions," FDA said in its warning letter.
It's the second time in recent months that India-based Sun has been slapped by FDA for trouble in its U.S. business. Last June, U.S. marshals raided three Michigan facilities operated by Caraco Laboratories, seizing drugs and stopping production because of alleged manufacturing violations. Caraco is still working to fix those problems so it can resume production at those plants, the Business Standard reports.
Sun says it's already working to correct the Cranbury problems and that it's committed to working with FDA to resolve them. In the meantime, Sun warned investors that, if it can't satisfy the agency, FDA may withhold pending applications for approval of proposed drugs to be made at the Cranbury facility.
- find the FDA warning letter
- see the release from Sun
- get more from the Wall Street Journal
- check out the Reuters story
- read the article in the Business Standard