FDA 483 - Unichem Laboratories Limited - July 15, 2024

An FDA inspection of Unichem Laboratories Limited in Pilerne Bardez, Goa, India, revealed significant deficiencies across multiple areas of drug manufacturing. Observations included a lack of an on-site Quality Unit, inadequate oversight of analytical equipment and out-of-specification results, and failures to follow production procedures. The firm also conducted inadequate investigations into microbial contamination and failed to maintain original electronic batch manufacturing records, indicating serious quality system breakdowns.