The US Food and Drug Administration has sent a notice to Hetero Labs, a supplier of active pharmaceutical ingredients, about possible manufacturing deficiencies at its unit located in Telangana. The FDA issued the Hyderabadbased company Form 483, which notifies a company of objectionable conditions at its manufacturing site that are potentially in violation of the regulator’s rules.
The 13-page observation by investigators Massoud Motamed and Latorie Jones noted several deviations that were against good manufacturing practices, including the shredding of documents, mismatch in batch records and failure to remove defective products from the market. EThas viewed the form.
Hetero did not immediately respond to an email seeking comment on the matter. The FDA inspected the company’s CCTV records and found that quality technicians and other individuals were seen destroying and altering records pertaining to commercial batch manufacturing immediately prior to the regulatory inspection. “A document shredder was introduced into your firm’s document storage area… days prior to the current US FDA inspection. After introduction of the document shredder we observed extensive shredding of what appears to be controlled documents and extensive signing of documents by QA,” the FDA investigators noted. The company failed to maintain a record of what had been shredded before the current inspection, the FDA said. It noted that the company’s staff shredded the documents in the middle of the night and were unable to explain their actions when they were questioned about it.
The 13-page observation by investigators Massoud Motamed and Latorie Jones noted several deviations that were against good manufacturing practices, including the shredding of documents, mismatch in batch records and failure to remove defective products from the market. EThas viewed the form.
Hetero did not immediately respond to an email seeking comment on the matter. The FDA inspected the company’s CCTV records and found that quality technicians and other individuals were seen destroying and altering records pertaining to commercial batch manufacturing immediately prior to the regulatory inspection. “A document shredder was introduced into your firm’s document storage area… days prior to the current US FDA inspection. After introduction of the document shredder we observed extensive shredding of what appears to be controlled documents and extensive signing of documents by QA,” the FDA investigators noted. The company failed to maintain a record of what had been shredded before the current inspection, the FDA said. It noted that the company’s staff shredded the documents in the middle of the night and were unable to explain their actions when they were questioned about it.
The FDA observed that as preventive and corrective actions, Hetero failed to remove defective products from the market and did not investigate or document complaints. Hetero is .`400 crore drug company that makes range of drugs, including anti-retrovirals, which are used in HIV treatment.