FDA 483 - Indoco Remedies Limited (Plant I) - October 18, 2023
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
Indoco Remedies Limited (Plant I) in Verna Da Gama, Goa, India, was inspected and cited for significant deficiencies across its manufacturing operations. The inspection revealed failures in equipment cleaning and maintenance, inadequate visual inspection programs for drug products, and a lack of thorough investigation into out-of-specification results and discrepancies. Additionally, the firm's quality control unit demonstrated a failure to fully follow its procedures, impacting data integrity and record-keeping.
ID · 827c9dfa-eba4-4c24-9439-1db2a1113374