The US health regulator USFDA has red flagged "deviations" from good manufacturing practices at Keshava Organics' Tarapur manufacturing facility in Maharashtra.
The USFDA has also withheld any approval to new application or supplement listing the firm as a drug manufacturer until the company corrects the deviations, according to a warning letter sent to the company.
Some of the concerns raised by the regulator are failure by the company to adequately investigate out-of-specification results and implement appropriate corrective actions at the facility and failure to maintain complete data for API tested and distributed to the US.
In the warning letter to the company's CEO Dinkar K Raut, the United States Food and Drug Administration (USFDA) said the letter summarises significant deviations of current good manufacturing practice (CGMP) for active pharmaceutical ingredients (API) at the facility.
"Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your API are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act...," the letter said.
Acknowledging that it has reviewed company's June 20, 2017, response in detail and is in receipt of the firm's subsequent correspondence, the USFDA said investigators observed specific deviations during the inspection.
One of the deviations observed by investigators was "failure to adequately investigate out-of-specification (OOS) results and implement appropriate corrective actions," the letter said.
It asked the management of the company to provide a retrospective review of all invalidated OOS (in-process and finished testing) results obtained for products on the US market.
The letter also asked the company to provide an independent assessment of its system for investigating OOS results. It also asked for a corrective and preventive action (CAPA) to remediate OOS investigations at the facility.
Another issue raised by the USFDA is that in several instances, the company failed to maintain complete data for API tested and distributed to the US.
The regulator said that the company in response to this letter should provide a comprehensive investigation into the inadequacies in data, records and reporting.
The letter also mentioned that "in previous inspections (May 1517, 2011, and April 1418, 2014), FDA cited similar CGMP deficiencies. You proposed specific corrections for these deficiencies in your responses. These recurring deviations demonstrate that your facility's oversight and control over the manufacture of drugs is inadequate."
Based upon the nature of the violations "we identified at your firm, we strongly recommend engaging a consultant qualified to evaluate your operations, and assist your firm in meeting CGMP requirements," the regulator recommended.
The letter however added that use of a consultant does not relieve firm's obligation to comply with CGMP and the it's executive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance.
"Until you correct all deviations completely and we confirm your compliance with CGMP, 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 Keshava Organics Tarapur plant in Maharashtra, into the United States, it added.
The USFDA has given the company time to respond within 15 working days after receiving the letter, asking it to specify what steps it has taken since May 2531, 2017 inspection by USFDA to correct deviations and to prevent their recurrence.
(This story has not been edited by Business Standard staff and is auto-generated from a syndicated feed.)
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