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# Cape Drugs FDA-483
- URL: https://www.fdaweb.com/cape-drugs-fda-483/
- Published: 2022-03-10T12:00:00.000Z
- Updated: 2026-09-14T17:36:00.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151339

FDA has released the FDA-483 issued following an 11/8-12/2/21 inspection at Valgene Incorporated, doing business as Cape Drugs, an Annapolis, MD, producer of sterile and non-sterile drug products. The four inspection observations were: 

- disinfectant contact time (dwell time) and coverage of the item being disinfected were insufficient to achieve adequate levels of disinfection;
- the ISO 5 classified aseptic processing areas had difficult to clean and particle-generating equipment or surface;
- the facility design allowed the influx of poor quality air into a higher classified area; and
- ISO 5 classified areas were not certified under dynamic conditions.