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The UK regulatory agency issues statement of noncompliance against Wockhardt?s site in Chikalthana, India and Wockhardt?s contract manufacturer Nestor in the United Kingdom.
The Medicines and Healthcare Products Regulatory Agency (MHRA) has issued a statement of noncompliance against Wockhardt's site in Chikalthana, India and the company's contract manufacturer Nestor in the United Kingdom. The issuance of noncompliance follows manufacturing problems for Wockhardt earlier this year at its site in Waluj, India.
"We have issued a statement of noncompliance against Wockhardt’s site in Chikalthana, India and Wockhardt’s contract manufacturer Nestor Ltd. in the UK after recent inspections identified a number of manufacturing issues that breach good manufacturing practice (GMP) guidelines," said a MHRA spokesperson.
“People should continue to take their medicines as usual because although the products have not been manufactured in line with GMP requirements, there is no evidence of a safety risk to patients," said the MHRA spokesperson. "We are working with the Department of Health to ensure that people have access to the medicines they need. Anyone who has questions should speak to their pharmacist or GP [general practitioner]," said the spokesperson.
In July 2013, MHRA issued a precautionary recall of 16 different prescription medicines made by Wockhardt at its Waluj site in India because MHRA identified manufacturing deficiencies during an inspection and noted that the medicines have not been manufactured to GMP standards. The recall was issued to pharmacies, dispensing clinics, and wholesalers, but not patients. The deficiencies identified by the MHRA during a routine inspection in March 2013 included a low risk of cross-contamination because of poor cleaning practices and defects in building fabric and ventilation systems at the site. There was also evidence of forged documents relating to staff training records that had been rewritten.
See related story, MHRA Recalls Medicines Made at Wockhardt's Waluj Site (July 2013)