New Delhi: The US Food and Drug Administration (USFDA) has issued a warning letter to Indoco Remedies for violating current good manufacturing practice norms at its plant in Goa.
In the warning letter, USFDA said its inspectors found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals at the site after inspecting it between 31 August and 4 September, 2016.
The significant violations included the company’s failure to follow adequate written procedures describing the handling of all written and oral complaints regarding a drug product, including provisions for review by the quality control unit, the USFDA said.
“This unreliable process compromises the quality, integrity, and sterility of solution. Although you implemented various corrective actions and preventive actions (CAPA) since 2013, you have continued to receive a large number of non- integrity complaints,” the letter noted.
The US health regulator also pointed out the company’s failure to ensure the responsibilities and procedures applicable to its quality control unit. “Your firm acts as a contract manufacturer for various drug products. Your failure to comply with CGMP may significantly affect the quality, safety, and efficacy of the drugs you manufacture for your clients,” USFDA said.
It is essential that the company understands its responsibility to operate in full compliance with CGMP, and to immediately inform its customers of production problems or quality issues that may pose a patient hazard, it added.
“Based upon the nature of the violations we identified at your firm, we strongly recommend engaging a consultant to assist your firm in meeting CGMP requirements,” USFDA said. Until the company corrects all violations and deviations completely and the USFDA confirms its compliance with CGMP, it may withhold approval of any new applications, it said.
“Failure to correct these violations may also result in FDA refusing admission of articles manufactured at Indoco Remedies Ltd, Plants II and III, L-32, 33, 34 Verna Industrial Estate Area, Verna, Goa, into the United States,” it added.