FDA 483 - Shriram Institute for Industrial Research - February 29, 2024

The FDA inspected Shriram Institute for Industrial Research in Delhi, India, a control testing laboratory, and issued a Form 483. The inspection revealed significant deficiencies including inadequate quality control unit procedures, unreliable electronic records and laboratory instrument validation, unverified testing methods, insufficient investigation of discrepancies, and a lack of cGMP/GLP training for employees. These issues indicate a systemic failure to adhere to good manufacturing and laboratory practices.