The FDA recently hit Dr. Reddy’s with a pair of Form 483s following inspections at two of the drugmaker’s manufacturing sites located in India.
Following an inspection conducted between May 30 and June 7, Dr. Reddy’s API plant in Pydibhimavaram, Andhra Prades, India, was cited with four observations that were mainly directed at the site’s quality control unit, the agency said in a letter (PDF) to the company posted on the regulatory agency’s website.
The FDA outlined a number of out-of-specification incidents that lacked proper testing and follow-up after API batches had been produced.
In one observation, the company was chided for failing to ensure that manufacturing processes were maintained in a validated state.
“API intended for use in U.S. marketed products were released by the quality unit without completion of all applicable release tests prior to distribution,” the FDA said.
In a separate case, Dr. Reddy’s was hit with a Form 483 in mid-May, according to a regulatory filing (PDF) by the company posted on the Bombay Stock Exchange.
In the posting, the company said its formulation manufacturing facilities in Duvvada, Visakhapatnam, India, were cited with two observations following a May 8 to May 17 inspection. Dr. Reddy’s didn’t provide details of the observations in the filing.