Numerous Complaints, Repeat Observations Fill FDA Warning Letter for Indoco
Goa, India-based contract manufacturer Indoco Remedies received a US Food and Drug Administration (FDA) warning letter late last month after the agency said its failure to comply with current good manufacture practices (CGMP) may significantly affect the quality, safety and efficacy of the drugs it manufactures.
From January 2012 to August 2016, FDA says Indoco received about 1,500 consumer complaints for “leaking, empty, and under-filled” bottles, which the company’s internal investigation found to be due to a filling machine issue.
But FDA says that it’s unclear whether corrective and preventive actions implemented in 2013 “sufficiently addresses the root causes of this recurring container-closure integrity defect and will correct the problem.”
And though the company’s health hazard evaluation from September 2016, “classified these defects as high severity, including potential for a serious permanent injury,” the company “concluded that the need for action is ‘moderate’” because it considers “the probability of patient exposure to the non-integral product to be low.”
The company also failed to notify its customers of some quality problems, and FDA said: “Your failure to follow the provisions of your quality agreement and appropriately notify your customer of the quality problems discussed in this letter may have delayed your customer's ability to take important actions to ensure the quality, safety, and efficacy of its products.”
Some observations were also found by FDA to be repeats from a previous inspection from 2011 with “17 complaints for leakage or crusty residue observed.”