New FDA Warning Letter for Wockhardt, Ltd. in India

Recommendation

26-28 October 2021

Bioassays and Bioanalytics + Stability Testing for Biological/Biotechnological Drug Substances and Drug Products - Live Online

This Warning Letter issued by the FDA to the Indian manufacturer Wockhardt Limited dated 23 December 2016 underlies an FDA inspection performed in December 2015.

The deviations observed include for example:

• Microbiological contamination of sterile APIs
• Inappropriate protection clothing in the sterile areas
• Incomplete data in the laboratory
• Insufficient access controls over computerised systems
• The activities performed haven't been recorded at time.

Regarding the laboratory records, the FDA inspection showed that the HPLC and GC analytics included OOS results. Deviating results have simply been excluded from the official records.

The company Wockhardt had originally responded that they have initiated a retrospective review of HPLC and GC data over a multi-year period. For the FDA, this response is inadequate as it doesn't explain how deep the review of the electronic data should be. The FDA expects a comprehensive review of all the systems in the laboratory.

A management strategy for a global CAPA correction measure is expected as "Data Integrity Remediation". These long-term measures should ensure the integrity of all data in the company in the future. 

A response to the FDA is required within 15 working days of receipt of this FDA Warning Letter.

To find the details please access the complete FDA Warning Letter for Wockhardt, Limited.