Warning Letter: Wockhardt

April 13, 2006
Pharmaceutical Technology Editors

ePT--the Electronic Newsletter of Pharmaceutical Technology

On Feb. 21, the US Food and Drug Administration issued a warning letter to Wockhardt (Mumbai, India), a drug manufacturer. FDA cited the company for violations of CGMPs in the manufacture of drug products and active pharmaceutical ingredients.

On Feb. 21, the US Food and Drug Administration issued a warning letter (www.fda.gov/cder/warn/2006/320-06-01.pdf) to Wockhardt (Mumbai, India, www.wockhardt.com), a drug manufacturer. FDA cited the company for violations of CGMPs in the manufacture of drug products and active pharmaceutical ingredients. FDA discovered the violations during its inspection of Wockhardt's Aurangabad, India manufacturing facility in November 2005 and listed them in a Form 483 issued to the company. Wockhardt responded in a letter sent Dec. 7, but FDA found the response inadequate.

FDA claimed that the company did not always follow written production and process control procedures and document them at the time of performance. In particular, FDA alleged that Wockhardt violated the process validation protocol for certain tablets by taking samples outside the allowed range. The agency also stated that Wockhardt's control records did not include complete and accurate information relating to batch production and control, a violation that FDA described as "serious." According to the warning letter, the company's management admitted that inappropriate documentation practices such as back-dating and signing for actions not performed occurred at the facility. FDA gave Wockhardt 30 days to respond to the warning letter.