Biocon Generics Inc. – FDA EIR, Sep 8, 2020

An FDA pre-approval inspection was conducted at EYWA PHARMA INC, located in Cranbury, NJ, from August 25 to September 8, 2020. This inspection, carried out under Compliance Program 7346.832, aimed to assess the facility's readiness for commercial manufacturing of oral solid dosage forms for Abbreviated New Drug Applications (ANDAs) #214426 (Potassium Citrate ER Tablets) and #213524 (Albuterol Sulfate Tablets), ensuring adherence to current Good Manufacturing Practices (cGMP).

At the inspection's conclusion, the FDA issued a Form 483 with three significant observations. These observations highlighted deficiencies in the quality control unit, specifically that its responsibilities and procedures were not adequately documented or followed. Furthermore, laboratory records were found to be incomplete, lacking comprehensive data from testing. Lastly, the firm did not exercise appropriate controls over computer systems to ensure that changes to master production and control records were only made by authorized personnel. The company's CEO acknowledged these deficiencies and committed to implementing necessary corrections.