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# Fresenius Hit With 11-Item FDA-483
- URL: https://www.fdaweb.com/fresenius-hit-with-11-item-fda-483/
- Published: 2024-12-09T12:00:00.000Z
- Updated: 2026-09-14T14:48:50.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158331

FDA has posted an 11-item [Form FDA-483](https://www.fda.gov/media/184171/download?ref=fdaweb.com) from a 10/2023 Fresenius Kabi Oncology inspection at the company’s Pradesh, India manufacturing facility. Significant GMP deficiencies cited in the form are:

- Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.
- Laboratory records do not include complete data derived from all tests, examinations and assays necessary to assure compliance with established specifications and standards.
- Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation for the aseptic process.
- Batch production and control records do not include complete information relating to the production and control of each batch.
- Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
- Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions.
- Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
- The responsibilities and procedures applicable to the quality control unit are not fully followed.
- Established test procedures are not documented at the time of performance.
- Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
- There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been distributed.