The U.S. Food and Drug Administration issued a Form 483 with eight observations about Dr. Reddy's Laboratories Ltd.'s manufacturing plant in Andhra Pradesh, India.
The U.S. regulator issues this form to companies to list violations observed during an inspection. Among the violations, the inspector noted that the quality control unit at Dr. Reddy's facility lacked authority to fully investigate errors that have occurred.
Additionally, the sterilization procedures to prevent microbiological contamination in the facility were not valid. The inspection also unearthed a quality deficiency in the filtered air supply and equipment to control air pressure, micro-organisms, dust, humidity and temperature.
The FDA observed that Dr. Reddy's could not justify deviations from production and process control procedures. Moreover, there were no control procedures to validate manufacturing processes that could cause variations in the characteristics of the drug produced.
