India's Indoco acknowledges Form 483

FDA sign

Indoco Remedies is the latest Indian drugmaker to run into issues with the FDA, having received a Form 483 with a half-dozen observations during a preapproval plant inspection.

The drugmaker last week issued a filing with the Bombay Stock Exchange saying that the FDA had inspected its Goa Plant II from Aug. 31 to Sept. 4 as part of an abbreviated new drug application for an injectable product. It received 6 observations. It said it expects to have taken “corrective and preventive actions” within 30 days. The company pointed out that none of the observations related to “data integrity.”  

That is probably because data integrity issues have been the downfall of a long list of Indian drugmakers. Many have been cited for repeatedly re-testing products to get passing test results then deleting failed tests, faking results, forging names on approvals or even fabricating data. Many of those cases have resulted in drug bans and FDA warning letters against many of India's leading drugmakers, as well as a host of smaller operators. 

Just last month, the FDA issued a third warning letter to India’s Pan Pharmaceuticals, a second for its Vadodara facility. In addition to serious sanitation concerns, the FDA said that Pan’s “quality unit failed to identify data integrity issues in 11 batch production records” and that the plant’s production manager “admitted that he falsified the signatures of other employees” on the approvals of the records.

Earlier in the month, the FDA had issued a warning letter to two of Unimark Remedies’ Indian facilities for issues that included poor record keeping.  

- here’s the BSE filing

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