- Hetero Labs Ltd. has received a warning letter from the Food and Drug Administration for production issues at one of the Indian drugmaker's manufacturing facilities.
- In a December inspection of the site, located in Polepally Village, Telangana, the agency identified equipment that hadn't been properly cleaned, as well as ineffective quality control and recall procedures.
- The FDA requested Hetero provide a review of its operations and plans to correct the plant's current good manufacturing practice (cGMP) violations. The agency also suggested the company hire a consultant to help it realign with cGMP standards.
Another week, another Indian manufacturing site under FDA scrutiny. So far this year, the agency's Center for Drug Evaluation and Research has issued more than 40 warnings letter, many of which addressed to Indian drugmakers and pertaining to the cGMP production violations.
The FDA isn't the only regulatory body keeping a close watch on Indian drugmakers. Last year, German inspectors from the Federal Institute for Drugs and Medical Devices added products from Artemis Biotech, an active pharmaceutical ingredient producer, to the country's important ban list. And earlier in 2017, the European Medicines Agency threatened to suspend from market medicines — some belonging to big pharma players — that had ingredients manufactured at Micro Therapeutics Research Labs.
Asian regulatory agencies have also signaled their intent to rev up investigations of Indian drugmakers.
In the meantime, those pharma companies have been hit hard. In 2016, Dr. Reddy Laboratories' went so far as to say that FDA inspections were hurting Indian drug exports.
Hetero Labs may be the latest Indian manufacturer to get on the FDA's bad side, but it has plenty of company. Divi's Laboratories Ltd., Sun Pharma Industries Ltd. and Dr. Reddy's Laboratories have all received Form 483s in the past year, meaning inspectors found potential violations of the Food Drug and Cosmetic Act or related legislation.
Hetero's record is far from clean, however. The FDA previously flagged late-night document shredding at one of the companies factories.
In a warning letter dated Aug. 15, the agency found additional operational issues at a Hetero facility. Among them, the company didn't get to the root cause of out-of-specification results for some tablets (of an unspecified medication) and failed dissolution testing. In addition, Hetero didn't properly clean or address white residue on some of its equipment; and didn't follow its own recall policies.
In one example, a 5 mg finasteride tablet was about twice the size as the other tablets in the bottle. After receiving a complaint about the oversized table, the company didn't issue a product recall for another five months, according to the FDA.