USFDA observations not serious, says Biocon

Company claims its arm Syngene had five FDA inspections in the past year and there was no adverse observation

The US Food and Drug Administration (USFDA) has made minor observations in a recent inspection of Biocon facilities in Bengaluru. The company said observations will not have a material impact on its operations.

"Biocon underwent a USFDA inspection in June 2015, wherein a few minor observations in the nature of recommendations were made by the regulatory team. All those have been considered by the company and closed out with the FDA," a Biocon spokesperson said.

"None of the observations were material in nature to impact any of our processes or business. All our facilities are fully operational," the spokesperson added.

In an interaction with Business Standard last week, Biocon chairperson Kiran Mazumdar-Shaw said the company was strict about compliance and adherence to good manufacturing processes.

"We are proud of compliance culture at both Biocon and Syngene. At Syngene, we had five FDA inspections in the past year and there was no adverse observation. Just two weeks ago, there was a surveillance audit in the clinical trials division. The FDA officials told us this audit will typify FDA audits as they are concerned about compliance. The inspection was done for two weeks and there were no adverse observations,'' Shaw said last week.

They complimented the company on its compliance, she added. ''Compliance is a cultural issue and has to flow down from the top. If the compliance culture is missing at the top it may lead to problems later. Our clients are delighted as we have received a clean chit from the FDA."