The United States Food and Drug Administration (FDA) has recently issued Form 483 to Lupin’s Goa plant. The inspection was carried out from 6th to 18th September, 2021 and closed with seven observations.
The observations received by the company are as follows:
- Investigations of an unexplained discrepancy did not extend to other drug products that may have been associated with the specific failure or discrepancy.
- In process, materials are not tested for strength and approved or rejected by the quality control unit during the production process.
- Examination and testing of samples did not assure that the drug product and in-process material conformed to specification.
- Establishment of the reliability of component supplier’s report of analysis is deficient in that the test reults are not appropriately validated at appropriate intervals.
- The procedures for annual qualiy standards record evaluation are deficient in that they do not address a review of returned drug product records for each drug product.
- The written stability programme is not followed.
- Access to the storage area for labels and labelling materials is not limited to authorised personnel.