FDA slams trio of Indian drugmakers with Form 483 filings after December inspections

Dr. Reddy’s Labs, Laurus Synthesis and Torrent Pharmaceuticals were each slammed with Form 483 filings from the FDA after the regulatory agency conducted a series of inspections in December.

Dr. Reddy’s was cited with three observations following an inspection conducted between December 4 and December 8 at the company's Bachupally R&D campus in India. During the inspection, the agency found deficient records-keeping procedures, which didn't feature a complete record of all data captured during testing.

The company was also found to lack detailed control procedures used to review technical data, the agency said in a letter posted to its website.

Dr. Reddy’s was also called out for a lack of employee training. Specifically, an employee in Dr. Reddy's quality unit was "overdue" on a required training for more than two years.

Meanwhile, Torrent Pharmaceuticals’ Chhatral facility in Gujarat, India, was inspected between December 5 and December 11 and was cited with three observations. The agency said the company’s problems centered on its quality system, which sometimes failed to review batch discrepancies.

The Torrent quality unit was also called out for not having responsibilities and procedures in writing and fully followed for formulation operations, and for not keeping equipment and tools clean enough.

Separately, in its Form 483, Laurus Synthesis was hit with four observations following a review of its Anakapalli manufacturing facility located in Andhra Pradesh, India. The observations included not adequately conducting investigations of unexpected occurrences, inadequate sampling plans for intermediates, and not maintaining, cleaning and storing equipment in a way to prevent contamination.

Laurus was also cited for keeping incomplete records related to batch production and control.

The FDA visited Laurus' site between December 4 and December 8, and again from December 11 to December 12.