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# FDA-483 Posted on Hybrid Pharma Inspection
- URL: https://www.fdaweb.com/fda-483-posted-on-hybrid-pharma-inspection/
- Published: 2019-09-16T12:00:00.000Z
- Updated: 2026-09-15T01:50:05.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145013

FDA has posted a [Form FDA-483](https://www.fda.gov/media/130512/download?ref=fdaweb.com) citing Hybrid Pharma (Deerfield Beach, FL) for significant GMP violations documented during a June inspection of the drug outsourcing manufacturer. For example, the company’s procedures designed to prevent microbiological contamination of its drug products did not include adequate validation of the aseptic and sterilization process. Aseptic processing areas are deficient regarding the system for cleaning and disinfecting to produce aseptic conditions, the inspection form said. And FDA said there are no written procedures for production and process controls designed to assure that the chug products have the identity, strength, quality, and purity they purport or are represented to possess.