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# 4 Observations on Indoco Remedies FDA-483
- URL: https://www.fdaweb.com/4-observations-on-indoco-remedies-fda-483/
- Published: 2019-07-09T12:00:00.000Z
- Updated: 2026-09-15T01:36:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144487

FDA has released the FDA-483 issued following a 5/27-6/4 inspection at Indoco Remedies, Vasco Da Gama, Goa, India. The four specific inspection observations were: 

- determinations of conformance to appropriate written specifications for acceptance are deficient for drug products;
- investigations of a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product;
- there is no written testing program designed to assess the stability characteristics of drug products; and
- written procedures are not established that describe the examinations to be conducted on appropriate samples of in-process materials of each batch.