After cGMP no-no's cited, Indian drugmaker says FDA accepts remedies

Cadila Healthcare has taken one major monkey off its back. The India-based drugmaker has sent word to investors that it has worked its way out of the FDA's doghouse. In the agency's letter to Cadila, The Economic Times reports, the FDA informed the company that corrections to deficiencies at its Moraiya plant pass muster.

As The Economic Times quotes, Cadila told its stock exchange that the "the warning issue is resolved." Presumably, the company took action to address a range of deficiencies cited in an FDA warning letter last summer, including poor record-keeping of microorganisms that cropped up in the Moraiya plant and misstating that one growth was "typical" when agency inspectors later confirmed that it was atypical, according to the FDA's warning letter.

Cadila faced some severe punishments for not correcting its mistakes. As the FDA stated in the warning letter, the agency has the authority to sit on approval applications for drugs made by the offending manufacturer. What's more, the agency can block U.S. imports of products or products with ingredients from the drugmaker's tainted plant if improvements aren't made. With problems at the plant brought into compliance in the eyes the FDA, as Cadila communicated they were, the company can steer clear of those sanctions.

- here's The Economic Times' report
- see last year's FDA warning letter

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