FDA Cites Indian API Maker’s Quality Unit

Indian API manufacturer Biocon was hit with a Form 483 for multiple failures in its quality unit.

A Biocon facility in Bangalore had no records of approving, quarantining and rejecting labels for its products, the FDA’s investigators found. The firm created labels using word processing software and did not verify batch numbers, inspection lot numbers or retest dates before placing them on containers, the agency said.

The investigators also found that the quality unit reviewed and approved master batch records without documenting critical process parameters.

In addition, the quality unit neglected to assess or verify the sterility of purchased materials. The unit performed supplier qualifications and gave its approval without ensuring the material containers were sterile when it received them.