FDA 483 - Hetero Labs Limited (Unit V) - December 16, 2016

This FDA Form 483 details multiple observations from an inspection, highlighting significant deficiencies in quality control, record-keeping, manufacturing processes, complaint handling, equipment maintenance, and data integrity.

**Observation 1: Quality Control Unit Responsibilities and Procedures Not Fully Followed** The firm's QA technicians and other individuals were observed destroying and altering commercial batch manufacturing records immediately prior to the inspection. Evidence includes: * A document shredder introduced into the "DOCUMENTS STORAGE AREA" four days before the inspection. * Extensive shredding of what appeared to be controlled documents (batch packaging and manufacturing records) and extensive signing of documents by QA. The firm failed to maintain a log of shredded documents. * A contract QA employee removing documents from the shredder and placing them in his pocket. * Individuals shredding documents in the middle of the night, which the firm attributed to cleaning staff. * Discarded controlled documents, including a post-dated balance printout for drug product (b)(4) (indicating date alteration), a "GMP REPORT" with a "PASS" result, an "Abort" event printout, and numerous documents with written numbers and signatures found in the scrap area. * Controlled documents, including original test results and cleanroom certification reports, found in trash bins. The firm's Quality Manager admitted failure to maintain a shred log, violating SOP QA001-11 regarding document loss prevention.