Indian Companies Stumble on Compliance Issues
Beleaguered Indian companies continue to stumble when it comes to quality issues, with generics maker Wockhardt conducting yet another recall, and active pharmaceutical ingredients makers Mahendra Chemicals and Nosch Labs racking up GMP deficiencies.
Wockhardt is conducting its third U.S. recall since the end of April — this time pulling 162,142 cartons of drugs used to treat high blood pressure and ulcers. The Mumbai-based firm is recalling the drugs after failing to adequately investigate customer complaints, according to FDA enforcement reports. The drugs were manufactured at Wockhardt’s Mumbai facility and distributed by Wockhardt USA.
Included in the recall are 24,496 cartons of amlodipine besylate tablets and 25,357 cartons of lisinopril tablets. Both drugs are used to treat high blood pressure.
Two antibiotics are also being recalled: 5,464 cartons of azithromycin tablets and 3,572 cartons of clarithromycin. Rounding out the recall are 97,837 cartons of famotidine tablets, used to treat ulcers in stomach and intestines, and 5,416 cartons of zonisamide capsules, a seizure treatment.
Wockhardt initiated the Class II recall on June 1. In May, Wockhardt recalled 93,393 bottles of blood pressure medicine captopril in the U.S. after discovering the tablets failed to meet specification for thickness. And in April, the drugmaker recalled all remaining product from its Waluj and Chikalthana, India, plants due to quality concerns.
Wockhardt did not return a request for comment by press time.
Meanwhile, Indian API maker Mahendra Chemicals was hit with an FDA warning letter for cGMP deviations including data integrity issues.
During the May 19 to May 24, 2014, inspection, FDA investigators observed employees completing batch production record entries days after the operations had ended, releasing lots without proper approval and making notes on loose paper to record original, critical data, then destroying the notes after transcribing them.
The Ahmedabad, Gujarat, India, firm also failed to secure access to data. Inadequate controls of the computerized analytical systems raise questions about the authenticity of data and the quality of the firm’s APIs, the July 13 letter says.
The FDA asked Mahendra to provide a comprehensive evaluation of the extent of inaccuracies in its reported data, a risk assessment of potential effects of drug product quality and a management strategy, including details of its CAPA plans. The agency recommended hiring an outside cGMP consultant.
Mahendra Chemicals did not respond to a request for comment by press time.
API Maker Nosch Labs Hit with 483
Meanwhile, Nosch Labs, a maker of active pharmaceutical ingredients, was hit with a five-observation FDA Form 483 after workers at its Veliminedu Village, Chityal Madal, India, facility were observed passing off APIs that failed to meet quality control standards.
During the April 27 to May 1 inspection, FDA investigators found that analysts repeatedly altered acquisition dates of APIs in 2012. There were also discrepancies in the testing records of APIs that the company couldn’t explain.
Nosch also lacked controls to ensure electronic records are equivalent to paper records and to prevent personnel from modifying or deleting information. The company did not return a request for comment by press time.
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