FDA 483 - R.L. Fine Chem Private Limited - April 14, 2023

R.L. Fine Chem Private Limited, an API manufacturer in Chikkaballapur, India, was cited with two observations during an FDA inspection. The firm failed to adequately investigate critical deviations related to stability chamber excursions and did not analyze stability samples within established timeframes. These issues indicate deficiencies in quality control and adherence to established procedures.