Pharmaceutical manufacturers in India and the United States are the latest to receive quality checks from the FDA – Endpoints News

Two drugmakers on opposite sides of the globe are facing heat from the FDA over several quality control issues.

Indian manufacturer Sun Pharma received a Form 483 following an FDA inspection of its Mohali plant from August 3-12.

The FDA found failures when reviewing unexplained discrepancies as to whether a batch had already been distributed on the site.

The investigation found that there were instances of backdating, but Sun’s report was not thorough enough for the FDA to assess the full extent of the infringement. Sun did not interview all of the quality assurance reviewers, but he did confirm the backdating of employees who initially denied the practice. Sun also failed to conduct a thorough review of other work performed by employees, according to the FDA report.

An audit to assess the risk of backdating was conducted in Sun’s GMP documents, but it did not include specific actions to identify whether the backdating was still in progress or to give the extent of the damage. . Other quality control employees were also not interviewed when assessing the scope of backdating in the QC lab.

Form 483 includes an accusation that a former employee alleged numerous backdated cases in the quality control lab. Documents were provided identifying a current employee involved in the backdating, but the former employee did not respond to requests for additional information.

The FDA determined that this still did not fully substantiate why there was not enough information to initiate an investigation, as there were other open investigations related to the backdating and forged signatures.

The investigation also revealed cross-contamination in the products and identified shared-use equipment as the likely root cause, but no specific source of contamination was determined, resulting in a product recall.

The FDA also found that sampling plans, testing procedures and lab control mechanisms were not documented, with records showing that the employee responsible for collecting samples did not enter buildings. where the samples had been collected or that the employee was in a different building. at the time the sample was documented as having been taken. These incidents have happened many times.

Written procedures were reviewed and approved by the quality control unit, with lab records being deficient and lab controls not including scientifically sound test procedures. Written procedures were also not followed when testing compounds.

Sun has had similar run-ins with the FDA before. A Form 483 from an inspection in May at its factory in Halol, India, showed 10 observations ranging from quality control issues to a lack of training. The company has now racked up its 11th 483 since 2016.

Similarly, a US manufacturer is also in the FDA’s crosshairs with another Form 483. Revance Therapeutics’ manufacturing site in the city of Newark, Calif., noted three issues reported by the FDA.

An inspection held in mid-July revealed that site deviations were not always initiated in accordance with deviation notification and handling standards. The FDA also found that some operations and cleaning operations did not contain adequate information to ensure consistent performance.

The site also did not have information about its work cell bank storage facility.

Manufacturing issues have already impacted Revance, as last year the biotech received a CRL for its Botox-based therapy for moderate to severe glabellar lines. Revance said the release stemmed from deficiencies at a manufacturing site. The 483 of this period showed that the test methods of the banks were not sufficient to monitor the quality and that the manufacturing process was different from that initially proposed for marketing.