After a pandemic-fueled lull the past few years, FDA inspections are back in full force. This week, a pair of Indian drugmakers have found themselves in the agency’s crosshairs.
The FDA has handed down a trio of Form 483s after recent inspections of three Indian drug plants. One write-up went to Intas Pharmaceuticals, while the other two were handed down to Ipca Laboratories.
First, the Intas wrist-slap: The FDA wrote up an Intas site in Ahmedabad, Gujarat, India, after inspecting the manufacturing facility from May 1 to May 12.
The FDA dinged Intas with a whopping 16 observations, chiding the company over incomplete batch production and control records, unaddressed production discrepancies, subpar written procedures and inadequate measures for preventing microbial contamination. Intas also took heat for lackluster cleaning, poor environmental control, insufficient computer oversight, missed equipment checks and lapses in quality control, among other violations.
On Intas’ batch production and control records, the FDA noted that “visual inspection data for finished parenteral drug products appeared to be routinely manipulated by your manual visual inspectors to stay just below the established reject particle limits.”
To make matters worse, the FDA observed a “pattern of visual inspection records being altered to change the reported counts from values that exceed the individual particle limits.”
Intas also struggled to appropriately lock down its computer systems to ensure they were only used by authorized personnel, the FDA said.
Ipca, meanwhile, took flak for lapses at Indian plants in Ratlam and Dhar, Madhya Pradesh, where the FDA carried out inspections from June 5 to June 13 and from June 15 to June 23, respectively. The regulator’s first site visit covered an active pharmaceutical ingredients (API) facility, while the latter inspection was at a pharmaceutical manufacturing plant.
The API plant received a 10-observation write-up that raised issues with batch failure investigations, the release of failed drug ingredients, poor testing procedures, production inconsistency, inadequate quality control, missed reporting and more.
At Ipca’s drug manufacturing site, the FDA listed 8 observations around similar problems with batch discrepancies, unestablished time limits, unverified stability testing, and poorly maintained equipment, among other problems.
Indian drugmaking operations have become a common target for the FDA, with firms such as Sun Pharma, Centrient, Cipla, Amneal and Dr. Reddy’s all coming under the regulatory microscope in recent months.
Back in December, the FDA issued an import alert to one of Sun’s drug manufacturing facilities in India, jeopardizing shipments from the plant to the U.S. market. That same month, Dutch antibiotics specialist Centrient received a regulatory write-up at its production plant in the Indian state of Punjab.
This past spring, meanwhile, Cipla endured a scathing report at its Pithampur facility, where the FDA excoriated the company for numerous testing and record-keeping procedures, plus a plethora of poorly-handled customer complaints.
And at Amneal Pharmaceuticals’ Indian injectables plant, the FDA during a December inspection uncovered numerous sanitary issues and observed employees working without protective eyewear. The agency also uncovered a “mold-like” substance in parts of the facility.