USFDA Warning Letter to Chemspec Over Serious Data Integrity Violations

Failure of Quality Unit

The Quality unit failed in ensuring control of cGMP documents and exercising basic responsibilities of oversight and control of electronic and paper documents:

• API batches were manufacture and released without creating, maintaining or QA reviewing batch records.
• Duplicate logbooks were maintained by Quality Unit, with multiple batch records issued for the same batch. In production batch records were observed with no control numbers or sign to show they were issued by Quality unit.
• Quality unit replaced original cGMP records and pages from batch production records and laboratory testing records. These were destroyed without any documentation. Blank forms used to replace original records were observed in production.
• Quality unit allowed production operators to retroactively complete batch records for steps completed previously. Production personnel who has not witnessed the batch operations were found documenting weights and measures of components, solvents, temperatures etc on API batch records in the production office.

Chemspec response to Form 483 attributed lapses to shortage of quality assurance personnel and misclassification of deviations as administrative corrections. FDA found the response inadequate highlighting that similar violations were noted during an inspection at the site in August 2024 which led to an Untitled Letter in February 2025. The Firm failed to reconcile all missing records or provide comprehensive evaluation or testing data of released batches. FDA has directed Chemspec to provide a comprehensive assessment and remediation plan, retrospective review of each batch released in the past and risks to patients due to data integrity issues in released batches.

• USFDA Warning letter Chemspec, India (December 2025)