Wockhardt Gets Another Warning Letter From U.S. FDA
Wockhardt receives yet another warning letter from U.S. FDA, yet again for the facility in Ankleshwar, Gujarat.
The U.S. Food and Drug Administration has found four violations and two deviations from current good manufacturing practice regulations at the Wockhardt Ltd. plant in Ankleshwar, Gujarat.
The Indian pharmaceutical company’s facility was placed by on import alert on August 5, 2016, the third company facility to be censured thus by the U.S. health regulator. This warning letter may lead to the FDA withholding approval of any new drug applications by Wockhardt.
The warning letter dated December 23, 2016 cites the company’s failure to
- establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile
- ensure that manufacturing personnel wear clothing appropriate to protect drug product from contamination...
- ensure that laboratory records included complete data...
- exercise appropriate controls over computer or related systems...
- record activities at the time they are performed, and destruction of original records
The letter also raises the issue of data integrity remediation.
Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. We strongly recommend that you retain a qualified consultant to assist in your remediation.U.S. FDA Warning Letter To Wockhardt (December 23, 2016)
The regulator has directed Wockhardt to correct all violations and deviations failing which it may “withhold approval of any new applications or supplements listing your firm as a drug manufacturer”.
In a financial presentation at the end of Q2FY17 the company said it had 82 ANDAs (Abbreviated New Drug Applications) pending for approval.
This warning letter serves as a further setback to Wockhardt that saw almost no growth in revenue in Q2FY17 (excluding one-offs) and profit fall to Rs 17 crore versus Rs 92 crore in the same quarter last year. On Tuesday the Wockhardt stock ended the trading session at Rs 666, not far from its 52-week low of Rs 627.
Wockhardt has yet to respond to BloombergQuint’s request for a comment on the development.