Intas received 16 “observations” on their Form 483 inspection report.
Indian generic drugs lab, Intas Pharmaceuticals, has failed again. Less than six months after its disastrous Nov. 2022 visit that led to a June 1, 2023 Import Alert for one of its facilities, Intas had yet another lousy inspection date with the Food and Drug Administration, this time in May.
Although not given another Import Alert by the FDA – a borderline useless restriction considering imports were never banned after that lackluster Nov. inspection – Intas received 16 “observations” on their Form 483 inspection report. These observations outline areas in which inspections found the lab, located in the state of Gujarat, to have failed to meet the FDA’s current good manufacturing practices guidelines for drugs sold in the United States.
On Intas’ batch production and control records, the FDA noted that inspection data for finished parenteral drug products – which are injections as well as implanted drugs injected through the skin – 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,” the FDA report dated May 1 states.
This seems to be a pattern.
On May 17, The New York Times wrote about how Indian pharmaceutical companies are in the spotlight, and not in a good way. Intas was one of the stars of the show. The Times wrote, sourcing from the FDA’s inspection report, that Intas “destroyed evidence” about drug manufacturing practices, which inspectors found in trash bags.
The FDA continues to allowe companies with shoddy quality control standards to sell medication to the coveted U.S. market. The FDA often states that the reason they are reluctant to slap companies with actual import bans is due to the fact that the U.S. does not produce a myriad of important, daily use generic drugs. Restrictions, the FDA says, would exacerbate drug shortages. Meanwhile, patients and doctors are sometimes forced to choose between drugs that may be tainted or lack efficacy, or go without.
Intas had 25 products, all in tablet form or injectables, that were part of the June Import Alert which, in theory, are supposed to be detained. Instead, Intas continues to sell pharmaceuticals to the U.S. despite its recent, poor performance during FDA inspections.
Intas is a global pharmaceutical player and is the No. 1 generic brand in the U.K., for example. It is mostly known for oncology products in the U.S.
The FDA also gave low marks to another Indian generic drugs maker recently.
According to Fierce Pharma on July 7, Ipca Laboratories Ltd got poor grades at two of its Indian labs in Madhya Pradesh state following FDA inspections there between June 5 and June 13 and again from June 15 to June 23.
This was the FDA’s first visit to those labs. Ipca is known for producing active pharmaceutical ingredients, key components to making finished drugs. The API plant received 10-observations on the FDA Form 483. The FDA said the lab did not have “scientifically sound test procedures”, but its drugs are still allowed in U.S. hospitals.
Ipca says it is one of India’s top exporters of APIs, serving over 70 countries around the globe. It sells valsartan, a blood pressure medication, to the U.S.
We are a group of doctors, patients, health care industry experts, and advocates fighting to ensure all generic medicines are safe, affordable, and always available. Unsafe generic drugs from foreign manufacturers in China and India have been sold in the U.S that have been contaminated with carcinogens and fake ingredients, fall apart when tested, and don’t work as they should. We are fighting back to ensure all generic medicines are safe, affordable, and always available. We want every American to be able to trust the generics they take—every pill, every vial, every time.