U.S. FDA Finds Quality Lapses At Biocon’s Bengaluru Facility

An inspection by the U.S. health regulator revealed ten lapses in quality at Biocon Ltd.'s manufacturing facility in Bengaluru. The observations pointed at aseptic practices, adding to the biotechnology company's troubles with this particular unit.

The U.S. Food and Drug Administrator (FDA) issued a Form 483, published on its website, after an inspection between May 25 and June 3, that BloombergQuint had reported earlier. The regulator's visit was part of the surveillance audit for a small molecule injectable, a Biocon spokesperson had said in a statement.

The Bengaluru facility has recently been the subject of intense regulatory scrutiny. In April the U.S. FDA has issued a Form 483 with eight observations. An inspection by the French regulator had also led to concerns regarding sterile products, biological medicinal products, packaging and quality control testing at the Biocon unit, according to a report filed on the European Medicines Agency's website.

Form 483 is used by the FDA to document and communicate concerns and violations discovered during plant inspections.

The observations listed in the U.S. FDA document are as follows:

• Observation 1: 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
• Observation 2: Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of sterilization process
• Observation 3: Aseptic processing areas are deficient regarding the system for monitoring environmental conditions
• Observation 4: Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written or followed
• Observation 5: Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards
• Observation 6: Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and arterials used in cleaning and maintenance operation
• Observation 7: The quality control unit lacks the responsibility and authority to approve and reject all components and drug products
• Observation 8: Employees engaged in the manufacture and processing of a drug product lack the training and experience required to perform their assigned functions
• Observation 9: Laboratory controls do not include the establishment of scientifically sound and appropriate specifications
• Observation 10: Procedures describing in sufficient detail the controls employed for the issuance of labeling are not followed