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# FDA Releases Apitoria Pharma FDA-483
- URL: https://www.fdaweb.com/fda-releases-apitoria-pharma-fda-483/
- Published: 2024-10-08T12:00:00.000Z
- Updated: 2026-09-14T14:43:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157934

FDA has released the form FDA-483 issued following a 9/23-9/27 inspection at the Apitoria Pharma Private Limited active pharmaceutical ingredient manufacturing facility in Telangana, India. The 10 inspection [observations](http://www.fda.gov/media/182545/download?ref=fdaweb.com) were:

- equipment used in the manufacturing of drug substances and intermediates is not of adequate upkeep to facilitate operations for its cleaning and maintenance;
- failure to establish adequate manufacturing instructions in the production records for drug substances and intermediates;
- failure to ensure training is regularly conducted by qualified individuals and covers, at a minimum, the particular operations that each employee performs and current good manufacturing practices as they relate to the employee’s functions;
- failure of the quality unit to review and approve all appropriate quality-related documents;
- the redacted water system design and the water sampling method to ensure the quality of redacted water are not adequate;
- failure to establish and follow written procedures for investigating critical deviations or the failure of intermediates and active pharmaceutical ingredient batches to meet specifications;
- the equipment is not adequately qualified;
- the equipment cleaning validation protocol is inadequate;
- failure to ensure that new and modified facilities and equipment are qualified; and
- failure of the quality unit to establish a system to release or reject raw materials, intermediates, packaging, and labeling materials.