Functional Lapses at Wockhardts U.S. Facility: USFDA
Lately US Food and Drug administration has confronted about 12 methodical faults in Wockhardt's US Amenity services in Illinois. During the inspection conducted early in this year, FDA found that the responsibilities and procedures applicable to the quality control unit were not in writing and fully followed.FDA mentioned in the report that the company failed to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or the batch has already been distributed. The Quality control unit lacked authority to review production records to assure no errors occurred and fully investigate errors that had occurred.
The FDA has already issued a warning letter to Wockhardt’s two facilities in India. Last year, FDA issued an import alert effectively a ban, against company’s Chikalthana plant in western India. And in May, FDA had imposed ban on company’s Walij facility.