The FDA cited an Indoco Remedies API facility in Goa, India, for serious quality failures and inadequate handling of complaints.
Indoco received approximately 1,500 complaints between 2012 and 2016 that its sterile solution bottles were leaking, empty or underfilled, the FDA said in a warning letter following an inspection of the facility in late August and early September 2016.
The agency found the defects were likely the result of improper bottle placement during filling, leading to cracks. Despite a company evaluation deeming the defects “high severity,” the company classed fixing the problem as a “moderate” priority.
The company said it has taken corrective actions since 2013, but it has continued to receive many complaints.