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# FDA Finds Violations at India’s Wockhardt Plant
- URL: https://www.fdaweb.com/fda-finds-violations-at-indias-wockhardt-plant/
- Published: 2016-01-28T12:00:00.000Z
- Updated: 2026-09-15T02:31:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134607

> An FDA-483 details violations found by FDA inspectors at the Wockhardt Shandra plant in western India, according to a Reuters [report](http://news.yahoo.com/fda-finds-indian-drug-maker-wockhardt-hid-failed-171825371--finance.html?ref=fdaweb.com) from Mumbai. The news account says that the 1/12 inspection report said that the results of 22 failed tests had not been recorded and that multiple data files had been deleted from some machines. It also said that pharmaceutical ingredients were not stored or labeled properly in that a rejected drug batch was stored in the “approved material” area and some batches did not carry expiry dates.  
>  
> Reuters says that two of the company’s eight plants in India already are banned by FDA from exporting to the U.S. due to quality concerns.