What made the US FDA issue a warning letter to Sun Pharma’s subsidiary Caraco?

The US FDA had issued a warning letter to Sun Pharma’s subsidiary Caraco Pharmaceutical Laboratories on Oct 31, 2008. The letter is now available on the FDA site detailing the reasons why the warning was issued. It points out deviations from current Good Manufacturing Practice (CGMP) regulations for medicines. These deviations were detected in an inspection between May 1 to June 11 2008, and are mainly due to issues related to quality control. The FDA letter says that Caraco’s quality control unit (QCU) failed to fully investigate the contamination of Tramadol HCI and Metoprolol Tartarate. The FDA is not happy with the way in which the investigation has been carried out. A detailed list of seven deviations had been pointed out to Caraco and the FDA is not satisfied with Caraco’s response to these.

Caraco has communicated several times to the FDA since then, and has promised to, among other things, make organisational changes, complete all delinquent incident reports, give training (to employees), hire consultants, and revise standard operating procedures and process parameters. But the FDA letter talks about “serious concerns regarding:
a) your firm’s compliance history including several past inspections that documented significant CGMP deficiencies,
b) the serious nature of the observed violations,
c) your plans for expansion under these violative conditions, and
d) the risk to consumers associated with the CGMP deviations involving potential product contamination.”

FDA has asked Caraco to take prompt action to correct these deficiencies. It has asked other regulators to take note of this when giving contracts and may also withhold approvals for export certificates and grant of pending new drug approvals. Caraco had announced on November 24 that it had replied to this letter and dealt with the issues raised. Now one must wait for the FDA response to know what happens next.

The Warning Letter.

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