FDA Warns Another Indian Facility for Data Integrity Problems

The FDA warned an Indian manufacturer to immediately stop ignoring poor test results, the second Indian facility in a week to get a warning letter for data integrity violations.

During a May 2014 inspection of Micro Labs Limited’s Bangalore facility, investigators discovered scores of laboratory test records with uninvestigated out-of-specification data. Micro Labs basically ignored the poor results, deciding not to investigate the cause of the OOS results, the FDA says in a warning letter released Tuesday.

The agency cites five examples of mishandled OOS results. In one case, Micro Labs ran three high performance liquid chromatography (HPLC) injections that showed samples were OOS. However, the test injections weren’t reviewed or evaluated when deciding whether to release the batch.

In another example, Micro Labs did the same thing for sample data acquired during a gas chromatography and ultra violet spectroscopy analysis. The extra data was stored on the instrument hard drives and not reviewed.

Further, the names assigned to many of the results were changed during testing, which obscured who actually performed the tests, the FDA says.

Micro Labs said it created a new standard operating procedure in February 2014 to ensure against improper testing practices, but the practice continued even after the SOP was approved, the Jan. 9 warning letter says.

The FDA told Micro Labs to hire a data integrity expert to audit the system. The agency also wants a detailed investigation into the extent of the data integrity deficiencies, a risk assessment on the impact these deficiencies have on product quality and a CAPA plan describing a path forward.

Earlier this week, the FDA released a warning letter to Apotex for failing to adequately record test results at a Bangalore site.

The FDA has started scrutinizing data integrity during inspections after finding egregious violations at several international facilities, and agency officials have urged drugmakers to include data integrity in any supplier audits.

Micro Labs could not be reached for comment by press time.

Read the warning letter at www.fdanews.com/02-04-15-MicroWarning.pdf. — Robert King