The USFDA had issued a Form 483 with five observations for Bengaluru unit.
Biocon share price fell 5.85 percent intraday on February 25 after detailed observations were issued for its Bengaluru unit by the US health regulator.
The stock, which has rallied 40 percent in the last six months, was quoting at Rs 305.00, down Rs 9.15, or 2.91 percent, on the BSE at 1113 hours.
CNBC-TV18 accessed the Form 483 issued to the biopharmaceutical firm's Bengaluru unit by the US Food and Drug Administration (USFDA).
The USFDA conducted a Pre-Approval Inspection (PAI) and GMP inspection of the API manufacturing facility in Bengaluru from January 20 to January 24. It made five observations in Form 483, the company told BSE .
- The cleaning validation protocols are not adequately performed;
- The company failed to adequately investigate non-conformances;
- Equipment used in production operations are not adequately qualified;
- The company failed to fulfill responsibilities of the quality control unit;
- The company failed to adequately handle, store & document material movement & status.
Last week, the USFDA also conducted a pre-approval inspection (PAI) of Biocon's subsidiary, Biocon Sdn. Bhd's Insulins manufacturing facility based in Malaysia, for Insulin Glargine, during February 10-21 and issued a Form 483 with three observations.The company believes these three observations are procedural in nature.