Indoco Remedies is not just getting the once over by the FDA but the twice-over as inspectors work through its plants and citations rain down.
The Indian drugmaker today acknowledged it has been slapped with an FDA warning letter for a plant in Goa that makes tablets and other products. But it didn’t announce it also was recently hit with a Form 483 for a nearby sterile injectables plant that was previously ripped in a warning letter.
In a press release the drugmaker, which has a history of manufacturing infractions, said it had already responded to a Form 483 and started remediation at the tablet plant in Goa before it was nailed with the warning letter. The six observation Form 483 for the plant in Vasco Da Gama, Goa cited serious data integrity issues as well as equipment cleaning problems.
"We have already done considerable remediation work and shall continue to implement necessary additional corrective actions,” Managing Director Aditi Kare Panandikar, said in a statement. “We are committed to being cGMP compliant and supplying quality products to our customers and the patients across the globe."
It may be committed to supplying quality meds, but the FDA has found Indoco has not consistently met those standards. The agency last month completed an inspection of Indoco’s sterile injectables plant in Goa that had been cited in a warning letter two years ago.
According to a Form 483 following the May/June inspection, the plant continues to have big issues with stability testing. The document gives a list of tests that didn't occur until after the samples had expired.
The 2017 warning letter for that sterile plant had found that for at least four years, Indoco had failed to fix a problem with a filling machine that resulted in cracked and leaking vials, even though it received more than 1,500 customer complaints during that time. And that was a repeat violation. The FDA said it had found similar issues during an inspection in 2011.
These kinds of infractions have been a running theme for the drugmaker, which has nine manufacturing facilities. Last year, European inspectors cited one of Indoco’s plants in Goa for manufacturing problems.
The manufacturing issues at the tablet plant may come with costs beyond the expense of fixing the problems. The drugmaker has one approved ANDA from the site for a drug that produces about Rs. 3 crore ($438,000) in annual revenue. The remediation could result in interruption of its production. Indoco also has four pending ANDAs which it acknowledged may be withheld while it fixes the plant.