The US health regulator has red-flagged significant violations of current good manufacturing practice (CGMP) regulations at drug firm Indoco Remedies' Goa facility, according to a warning letter issued by the USFDA.
Stating the specific violations, the US Food and Drug Administration (USFDA) said the firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced.
Pointing out another violation, the regulator said, the "firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed".
USFDA had inspected the company's Goa facility from January 17 to 25, 2019.
Another violation mentioned by the regulator said the firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards.
On the data integrity remediation, the letter said, the company's "quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness and quality of the drugs you (the company) manufacture".
It strongly recommended that the company retains a qualified consultant to assist in its remediation.
The regulator, in its letter made public on July 23, said it has reviewed company's February 15, 2019, response in detail and acknowledged receipt of its subsequent correspondence.
The letter to Indoco Remedies Chairman Suresh G Kare also said that the "firm does not have an adequate ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality".
The regulator also said the company was responsible for investigating these violations, for determining the causes, for preventing their recurrence, and for preventing other violations.
"Until you correct all violations completely and we confirm your compliance with CGMP, FDA may withhold approval of any new applications or supplements listing your firm (Indoco Remedies) as a drug manufacturer," the letter said.
In a regulatory filing on July 15 this year, Indoco Remedies had said that it had received a warning letter from the USFDA, and had said it would respond to the warning letter within stipulated time. It, however, had not provided the details about the violations pointed out by the regulator in the letter.