US Food and Drug Administration (FDA) inspectors visited the plant in Jiutepec, Mexico towards the end of 2010 and alerted Dr Reddy's to shortcomings at the operation. Having reviewed Dr Reddy's response, the FDA has sent a warning letter outlining its concerns about practices at the active pharmaceutical ingredient (API) plant.
Failure to validate analytical methods used to test APIs is one deviation cited by the FDA. “For example, the inspection revealed that your firm has not validated the HPLC (high-performance liquid chromatography) method for assay and related substances of [an unnamed finished API for human use]”, said the FDA.
Numerous other methods also lacked validation. Dr Reddy's sent a response to the FDA but the agency deemed it to be insufficient and asked the Indian generics giant to provide “a plan that details a greater level of assurance that adulterated API will not reach the US market”.
Other problems raised by the FDA fall into three broad categories. First, the FDA said cleaning validation for non-dedicated manufacturing equipment was incomplete. For example, and FDA found others, manufacturing equipment in one area lacked documented cleaning validation.
Also, out-of-specification (OOS) investigations failed to include analysis of all available data. OOS investigations also suffered from deficiencies related to timeliness, failure to follow written procedures and four to eight-months delays for reporting failing stability batches.
Collectively these problems amount to a failure to ensure APIs are produced in compliance with current good manufacturing practices (cGMP), said the FDA. In its December 2010 response to the FDA's initial concerns Dr Reddy's said it would assess its quality unit by the end of April 2011.