Following reports of destroyed and discarded data, the U.S. regulator issued a warning letter to India’s Intas Pharmaceuticals regarding violations of current good manufacturing practice.
Pictured: FDA sign at its headquarters in Washington DC/iStock, JHVEPhoto
The FDA on Friday issued a warning letter to India-based generics manufacturer Intas Pharmaceuticals citing several quality control issues at its Sanand plant, including “significant violations” of current good manufacturing practice as well as destroyed and discarded data.
The letter revealed that in November 2022 an Intas analyst was seen pouring acetic acid into a trash bin that was containing current good manufacturing practice (CGMP) records. A quality control officer had also witnessed the same analyst destroy data sheets including balance printouts and titration curves. The employee reported these incidents to company management but Intas did not launch an investigation until a week later, according to the FDA’s letter.
Another Intas analyst, after weighing out amitriptyline hydrochloride tablets multiple times, told FDA investigators that he did not report all of the results. In other instances, the analyst said, he would throw away balance printouts.
FDA investigators also found plastic bags full of discarded CGMP documents across the manufacturing facilities, suggesting that Intas had gotten rid of Environmental Monitoring Systems engineering checklists, several analytical test reports, titration curves and balance weight slips for drug products.
Intas had been made aware of these infractions, among several others, in a 36-page document issued last December 2022. The FDA detailed these issues again in Friday’s warning letter, adding that while Intas had previously promised to work with consultants to evaluate its data governance protocols, its efforts had so far still not met the FDA’s requirements.
“Your response is inadequate in that it did not fully evaluate the scope of this deficiency and the impact to product quality,” the FDA said in the warning letter. “You did not adequately address the major failure of laboratory, operations, and quality assurance management to conduct proper oversight over documentation and prevent data integrity lapses.”
As of June 1, Intas is on the FDA’s Import Alert list, which allows the regulator’s field staff to detain products from the company even without physical examination, given repeated evidence of its CGMP violations. The alert covers several cancer drugs, including carboplatin and cisplatin, which are currently in critical short supply in the U.S.
In an interview with BioSpace last month, Erin Fox of the American Society of Health-System Pharmacists said that Intas had been responsible for approximately half of the supply of these two drugs, and that the closure of its Gujarat facility could have contributed greatly to the current shortage crisis.
Currently, the FDA has resorted to importing these drugs from other manufacturers in other countries, announcing in May that it would source cisplatin from Chinese drugmaker Qilu Pharmaceuticals. This is only a temporary fix, however, as strong legislative incentives are needed to produce these medicines domestically.
Last week, House Republicans released a draft bill designed specifically to address the drug shortage and prevent a similar crisis from happening in the future. One of the draft’s provisions is to launch a pilot program to accelerate the licensing of domestic manufacturing facilities.
Tristan Manalac is an independent science writer based in metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.
