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Wockhardt Limited at Gujarat received a warning letter from US FDA along with an Import alert.

US FDA issued a warning letter, dated 23 December 2016, to Indian manufacturing facility Wockhardt Limited, located at Ankleshwar, Gujarat. FDA had inspected this facility in December 2015 and issued a warning letter. The firm provided its response in January 2016, and also stated that the firm has initiated a retrospective review of all electronic data over a multi-year period. FDA found this response as inadequate as it did not explain the depth of the review. FDA placed this firm on Import Alert in August 2016.

Following violations were observed
1. Failed to follow the established procedures to prevent microbiological contamination of drug products.
2. Failed to prevent the drug product contamination with the appropriate clothing of manufacturing personnel.
3. Failed to ensure the availability of complete laboratory records to assure compliance with established procedure.
4. Failed to implement appropriate controls over computer or related systems in master production and control records
5. Failure to record activities performed online. Observed that the data was recorded in personal diaries (unofficial notebooks) and destruction of CGMP Documentation.
6. Firm quality system does not ensure the accuracy and integrity of data of the drugs being manufactured.

In response to the warning letter, FDA asked firm to provide the following.

1. A comprehensive investigation for the inaccuracies in documentation.
2. A current risk assessment of the potential effects of the observed failures on the quality of drugs.
3. A management strategy including global corrective action and preventive action plan.

Firm has to provide its response within 15 working days, specifying the activities performed to correct the violations and deviations and to prevent their recurrence. FDA recommended the firm to retain a qualified consultant to assist in remediation. Until all the violations and deviations are corrected completely, FDA may withhold approval of any new applications or supplements listing the firm as a drug manufacturer.



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