Biocon's Bengaluru plant had inspected by USFDA between March 27 to April 7, 2017 and USFDA issued form no. 483 to Biocon, largest biotechnology company of India. USFDA observed total 8 issues which were shared with the company. Shares of Biocon fell down after this reports circulated in media.
As per USFDA they issued form 483 to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
Observations by FDA are as below:
1. There are discrepancies between the information submitted and manufacturing process performed
2. The Quality assurance unit has approved and implemented documents that do not assure appropriate production, testing, and deviation review and release of commercial material.
3. Handling of in-process samples is inadequate.
4. There is a lack of quality oversight in the review of procedures followed in the quality control testing of drug substance and drug product.
5. The OOS procedure [out of specification procedure for non-conforming materials and drug products] does not ensure satisfactory conformance to batch release specifications and appropriate investigation and tracking of OOS events because it is internally inconsistent and not clear.
6. Solutions used for drug substance formulation do not have adequate microbial control.
7. Bioburden sampling during manufacturing of drug product is inadequate.
8. Deviations are not initiated and closed in time as per Deviation SOP.
Spokeperson from Biocon said, "Observations on form 483 is a standard outcome of any audit. Biocon has already responded to USFDA on all observations of the recent audit within stipulated timelines."
As a policy we do not comment on any schedule or outcomes of regulatory inspections, unless we believe that there is a material impact. Biocon has a good track record of inspections by the USFDA, European regulators and other regulators from developed and emerging markets, He added.
