FDA Warns Wockhardt Over Violations at Illinois Plant
Inspections at beleaguered Indian generics firm Wockhardt’s Illinois plant have turned up quality control issues ranging from poor cleanliness to shoddy product testing and incomplete record-keeping, the FDA said.
In a 483 inspection report to Wockhardt dated March 26 and released May 30, the FDA investigator identified multiple violations during a series of inspections from January to March at the firm’s Morton Grove Pharmaceuticals facility.
Among them, the plant’s quality-control unit did not fully monitor systems designed to assure the safety and quality of drug products, the investigator wrote. The facility also failed to keep complete records, he said. The records that are kept, however, are easy to delete. A general login on one computer “allows data stored on the hard drives of these instruments to be changed or deleted by any user,” the inspector noted.
Other violations included:
- Wockhardt doesn’t thoroughly review batch failures and unexplained discrepancies. It fails to document out-of-specification investigations, doesn’t differentiate between different kinds of investigations and doesn’t properly catalogue its findings.
- The quality control unit itself lacks the necessary authority to review records and track data.
- Not all workers receive the necessary current good manufacturing practice (GMP) training.
- Sanitary conditions are not adequately maintained. At least one worker was seen moving through the gowning area and into the drug manufacturing area without scrubbing up first. The catch basin of a hand dryer isn’t sufficiently clean and allows water to pool instead of fully draining.
This is not the first time Wockhardt has had GMP violations, a problem that has hit other Indian drug firms as well. Wockhardt’s recent troubles include bans on five of its products in the U.S. and recalls of 16 more in the UK.
Wockhardt did not return a request for comment by press time.
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