FDA Micro Lab Data Concerns Continue with Warning Letter to Second Indian Firm

A warning letter to Ahmedabad, India-based Cadila Healthcare, issued by FDA’s drug compliance office in late June, is the second in as many months to cite an Indian sterile product manufacturer for recording air sampling plate counts that did not match what agency investigators observed during the inspection.

The same issue of micro lab data integrity was prominent in a warning letter issued to Aurobindo Pharma in late May regarding its manufacturing operations in Hyderabad, India (IPQ “In the News” June 13).

As in Aurobindo’s case, Cadila was cited for reporting results for micro plates used as part of the firm’s environmental monitoring (EM) effort as “NIL” – meaning no growth – when agency investigators reviewing the plates observed growth.

[More on the Cadila warning letter and the similarities of the findings cited to those at Aurobindo and other recent warning letter recipients where lab data integrity was at issue is available for subscribers here.  Nonsubscribers can purchase both stories for $195 by contacting Karen Bertani (Jonathan@ipq.org).  For subscription/license information, click here.]