The US FDA issued a Form 483 — a form listing violations — after an inspection between May 25 and June 3. Biocon says it has responded with corrective measures
Biopharmaceutical firm Biocon was issued 10 observations by US drug regulator found lapses of current good manufacturing practices (cGMP) at its small molecule injectable plant in Bengaluru.
The US FDA issued a Form 483 — a form listing violations — after an inspection between May 25 and June 3. The FDA issues a Form 483 if its investigators spot any conditions that in their judgement may constitute violations of the US Food Drug and Cosmetic (FD&C) Act and related laws.
Moneycontrol verified a copy of the Form 483, which was made public by US FDA on its website.
The observations listed by the US FDA Form 483 document include
— Investigations of an unexplained discrepancy did not extend to other batches of the same drug product and other drug products that may have been associated with specific failure or discrepancy.
— Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of sterilisation process.
— Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
— Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written or followed.
— Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.
— Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in cleaning and maintenance operation.
— The quality control unit lacks the responsibility and authority to approve and reject all components and drug products.
— Employees engaged in the manufacture and processing of a drug product lack the training and experience required to perform their assigned functions.
— Laboratory controls do not include the establishment of scientifically sound and appropriate specifications.
— Procedures describing in sufficient detail the controls employed for the issuance of labeling are not followed.
"The USFDA visit in May/June was a part of the regulator periodic audits for a small molecule injectable," a Biocon spokesperson said in a statement.
"The company has responded to the regulator with a Corrective and Preventive Action Plan (CAPA) and is on track to implement them in a timely manner," according to the statement.
US FDA inspections are more rigorous when it comes to injectable plants.
The Bengaluru facility has recently been the subject of intense regulatory scrutiny. In April, the US FDA has issued a Form 483 with eight observations.An inspection by the French regulator ANSM as part of European Medicines Agency (EMA) review of company's biosimilars marketing authorisation also expressed concerns regarding sterile products, biological medicinal products, packaging and quality control testing at the Biocon unit.