Alkem Laboratories subsidiary, Enzene Biosciences, successfully concluded a Pre-Approval Inspection (PAI) by the USFDA on February 13, 2026, at its Chakan, Pune manufacturing facility. The inspection resulted in a Form 483 issuance, noting 6 procedural observations. Importantly, Enzene reported zero observations related to data integrity or the reliability of regulatory filings, and is currently preparing its formal response to the agency.
USFDA Inspection Outcome at Enzene Biosciences
Alkem Laboratories Ltd. officially announced the conclusion of a Pre-Approval Inspection (PAI) conducted by the United States Food and Drug Administration (USFDA) at its subsidiary’s manufacturing unit. The inspection took place at the facility operated by Enzene Biosciences Limited, located in Chakan, Pune, concluding on February 13, 2026.
Observations Noted
Following the review, the USFDA issued a Form 483, which details observations noted during the inspection process. Enzene received a total of 6 procedural observations. A significant positive highlight mentioned by the company is that Enzene achieved Zero observations pertaining to critical areas such as data integrity and the validation of quality systems, along with the reliability of regulatory filings.
Next Steps
Enzene Biosciences is actively engaged in preparing its comprehensive response to the USFDA. The subsidiary has also commenced the initiation of necessary corrective and preventive actions to address the noted procedural points within the stipulated regulatory timeline.
Source: BSE
