FDAnews Drug Daily Bulletin


April 20, 2006

The FDA has issued a warning letter to Indian drugmaker Wockhardt, citing violations of current good manufacturing practices (cGMPs) at its facility in Aurangabad, India.

The warning letter centered on cGMP violations in the manufacture of drug products and active pharmaceutical ingredients (APIs).

The FDA inspected the facility Nov. 8-11, 2005, and issued the company a Form 483. The company responded in a Dec. 7 letter, which the agency found inadequate.

The warning letter claims Wockhardt violated the validation protocol for a drug (name redacted) in that amounts of material were tested exceeding the range allowed. Documentation of environmental monitoring was also delayed for eight months, and when provided it consisted of an employee preparing a drawing from memory for the investigator, the letter said.

The FDA also found that "control records do not include complete and accurate information relating to the production and control of each batch." The letter acknowledged the company had revised its standard operating procedure (SOP) for storage, preparation and sterilization of the drug but had not indicated how it knew whether a certain necessary addition was made in the past - even though the inspection turned up "extremely low counts on your environmental monitoring." The company's logbook also "did not contain complete and/or accurate documentation," the letter said.

"Complete, true and accurate records are the foundation for good GMPs," the letter noted, adding that in a May 7, 2004, regulatory meeting between the agency and company officials, "management indicated to us that inappropriate documentation practices have occurred at your facility. Practices such as back dating and signing for actions not performed are serious violations."