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# U.S. Specialty Formulations Cited on Inspection
- URL: https://www.fdaweb.com/u-s-specialty-formulations-cited-on-inspection/
- Published: 2019-09-30T12:00:00.000Z
- Updated: 2026-09-15T01:53:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5145127

FDA has posted an 11-item Form[ FDA-483](https://www.fda.gov/media/131067/download?ref=fdaweb.com) to U.S. Specialty Formulations after concluding an inspection in July of its Bethlehem, PA manufacturing facility. According to the form, FDA cited it for not having written procedures for production and process controls. It also found that results of stability testing are not used in determining expiration dates. Additionally, the inspection said the company’s testing for product release does not include an appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient.