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US Food and Drug Administration (USFDA) has red-flagged significant deviations from manufacturing norms at the Bengaluru-based API facility of Resonance Laboratories, including failure to have adequate cleaning procedures to prevent contamination of products.
Summarising the deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (APIs), the USFDA said it had inspected the drug manufacturing facility on May 2-6, 2016.
"Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your APIs are adulterated within the meaning of the Federal Food, Drug, and Cosmetic Act (FD&C Act)," the USFDA said in a warning letter.
The letter, addressed to the company's director Tushar B Gore, said the response of the company after inspection of the facility was "inadequate".
Although the company committed to addressing issues identified with the water systems and cleaning validation, the overall response lacked details, the USFDA said.
"You also did not include a retrospective review of CGMP deficiencies on the quality of your products already distributed to the United States," it added.
The USFDA investigator had noted failure to validate that water system at the facility is capable of consistently producing water suitable for its intended use.
Another deviation was "failure to have adequate cleaning procedures to prevent contamination or carry-over of a material that would alter the quality of the API", the letter said.
"Based on the nature of the deviations we identified at your firm, we strongly recommend engaging a consultant to assist your firm in meeting CGMP requirements," it added.
Until the company corrects all deviations completely that are subsequently confirmed by the regulator, "FDA may withhold approval of any new applications or supplements listing your firm as a drug manufacturer", the letter said.
Failure to correct these deviations may also result in FDA refusing admission of articles manufactured at Resonance Laboratories at the Bengaluru plant into the United States, it added.