Cadila plant in India gets FDA warning
pharmafile | July 11, 2011 | News story | Manufacturing and Production |Â Â Cadila, FDA warning letter, pharma manufacturing newsÂ
Indian drugmaker Cadila Healthcare has been taken to task by the US FDA for quality violations at a new sterile injectables unit located at its manufacturing facility in Gujarat in a warning letter.
An inspection of the finished dosage form plant earlier this year revealed major deviations from GMP, focusing mainly on inadequate procedures for quality control such as record keeping and microbiological testing.
The main focus of the plant in Sanand is the manufacture of tablets, capsules and softgel capsules, but Cadila is in the process of establishing a new aseptic production unit for injectable drugs in both sterile liquid and lyophilised form.
The new unit is currently in the start-up phase, and the FDA visit took place as part of the pre-approval inspection procedure.
During the inspection, microbiologists at the facility had recorded some air sampling tests in aseptic areas of the facility as having no colonies, even though there were bacterial colony-forming units (CFUs) present, according to the FDA letter.
Microbiological growth that was detected was not identified correctly, continues the agency, and in one observed case this meant that a follow-up investigation was not carried out, as warranted by Cadila’s standard operating procedures.
Moreover, Cadila’s quality control unit “has not established or followed appropriate written procedures designed to prevent microbiological contamination of drug products purporting to be sterile”, according to the FDA.
The agency inspected the plant between 17 January and 3 February, and gave Cadila 15 days to respond to its warning letter, which was dated 21 June.
Failure to address the deficiencies could lead the FDA to block approval of injectable generics manufactured at the plant. Cadila has 18 Abbreviated New Drug Applications submitted with the agency for injectables.
Phil Taylor
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