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# 29-Page Intas FDA-483
- URL: https://www.fdaweb.com/29-page-intas-fda-483/
- Published: 2023-07-10T12:00:00.000Z
- Updated: 2026-09-14T18:42:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154837

FDA has released the 29-page form [FDA-483](https://www.fda.gov/media/170051/download?ref=fdaweb.com) with 16 observations from a 5/1-5/12 inspection at an Intas Pharmaceuticals drug manufacturing facility in Ahmedabad, Gujarat, India. News accounts have cited the company as being involved in the current shortage of the oncology drug cisplatin. The specific inspection observations were:

- failing to have batch production and control records include complete information on the production and control of each batch;
- failing to thoroughly review any unexplained discrepancy, whether or not the batch has been already distributed;
- failing to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess;
- failing to have procedures designed to prevent microbiological contamination of drug products purporting to be sterile to include adequate validation of the aseptic and sterilization process;
- aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions;
- aseptic processing areas are deficient regarding the system for monitoring environmental conditions;
- failing to exercise appropriate controls over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel;
- failing to perform routine checking of automatic, electrical, and mechanical equipment according to a written program designed to assure proper performance;
- failing to fully follow the responsibilities and procedures applicable to the quality control unit;
- failing to maintain at appropriate intervals equipment and utensils to prevent contamination that would alter the safety, identity, strength, and quality or purity of the drug product;
- equipment used in the manufacture, processing, packing, or holding of drug products is not of appropriate design to facilitate operations for its intended use;
- procedures for the annual quality standards record evaluation are deficient in that they do not address a review of a representative number of approved and rejected batches;
- procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not (sic);
- procedures for the cleaning and maintenance of equipment are deficient regarding the removal or obliteration of the previous batch identification;
- laboratory records do not include data derived from all tests, examinations, and assay necessary to assure compliance with established specifications and standards; and
- failing to establish and document the accuracy, sensitivity, specificity, and reproducibility of test methods.