New Delhi: Indian pharma company Wockhardt today announced it was recalling from America 13 drugs manufactured at two of its plants in Maharashtra where US drug inspectors had alleged violations of good manufacturing practice (GMP) rules two years ago.
The US Food and Drug Administration had placed import restrictions on products manufactured at the company’s plants in Chikalthana and Waluj after its inspectors in 2013 identified “significant violations” of GMP regulations for finished pharmaceuticals.
“As a measure of preparedness and as an abundant precaution, the company has now decided to recall, as a part of remedial measures all the remaining batches (of drugs) in the USD market that were manufactured prior to the USFDA import alerts even though there is no evidence of risk to patient safety from the products currently available in the US market,” Wockhardt, according to PTI, said in a filing to the BSE today.
The Waluj facility makes several injectables and solid drugs while the Chikalthana plant was under the USFDA import alert for a drug used to treat blood pressure. The company said several batches of products manufactured before the import alert might still be in the US market.
Wockhardt did not respond this evening to queries from The Telegraph about the names of the 13 drugs and whether products from the two plants had been distributed in the Indian market.
In July and November 2013, the USFDA had written to the company saying its investigators had identified GMP violations. In one of the examples cited, the investigators claimed to have found in Waluj unofficial batch records – for about 75 batches of injectable finished products -torn in half in a waste area.
The USFDA had noted that these records contained data indicating some batches had failed to meet the in-process visual inspection specifications of not more than four per cent defects. The documents, it said, suggested that 14 per cent of the vials had defects.
While the firm’s procedures require that a defect rate higher than four per cent be investigated, a senior production officer of the firm had allegedly told the USFDA investigators that no investigations are done when this occurs.
At Chikalthana, the USFDA had said, the company had failed to ensure that its laboratory records included complete data derived from all the tests necessary to ensure compliance with established specifications and standards.
The investigators also claimed to have observed two open bottles and missing capsules that the plant’s quality control could not explain.
Wockhardt shares ended the day at Rs 1,243.35 apiece, down 6.52 per cent from the previous close on the BSE, the PTI report said.
