Par Formulations Private Limited – FDA 483, Jun 10, 2026

Par Formulations Private Limited in Chennai, India, received a Form 483 for significant quality control deficiencies during an FDA inspection. The firm failed to thoroughly review out-of-specification (OOS) results and determine their root causes for distributed US marketed drug products. Additionally, the inspection revealed failures to submit timely Field Alert Reports and to adequately document required sample sizes in analytical methods for drug product testing.