The US Food and Drug Administration (USFDA) has issued a warning letter to Baxter-owned Claris Injectables for violating current good manufacturing practice norms at its Ahmedabad-based plant.
In the letter, the USFDA said inspectors during July 27, 2017 to August 4, 2017, had found significant deviations from standard manufacturing practices at Baxter (Claris Injectables Ltd) Ahmedabad-based plant.
The significant violations included failure to maintain plant premises and thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, the US health regulator said.
The USFDA said that drug firm failed to maintain buildings used in the manufacture, processing, packing or holding of drug products in a good state of repair.
"Our investigators observed significant evidence of water damage in your facility, including warped ceiling panels, puddles of water, and water stains," it said.
In addition, USFDA investigators observed ceiling panels over the personnel corridor that were not sealed, allowing ingress of air from the building's plenum into post-sterilisation areas, it added.
"It is essential that your plant management maintains the facility in a good state of repair to ensure ongoing suitability for drug manufacturing," USFDA said.
Besides, the US regulator pointed out the company's failure to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced.
"Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture," it said.
Based upon the nature of the violations, the USFDA also suggested the company to engage a qualified consultant to assist the drug firm in meeting CGMP requirements.
"We also recommend that the qualified third party perform a comprehensive audit of your entire operation for CGMP compliance, and evaluate the completion and effectiveness of any corrective actions and preventive actions," it said.
Until all corrections have been completed and FDA has confirmed corrections of the violations and the firm's compliance with CGMP, FDA may withhold approval of any new applications or supplements, the USFDA said.
In addition, the company's failure to correct these violations may result in FDA continuing to refuse admission of articles manufactured at the plant into the US, it added.
The FDA issued the letter on July 5, and has given the company 15 days to respond. The company could not be reached for comments over the FDA letter.
Last year, Baxter International Inc completed the acquisition of Claris Injectables, a wholly-owned subsidiary of Claris Lifesciences Limited, for a total consideration of USD 625 million.
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