# FDA 483 - Acuity Specialty Products, Inc - March 14, 2025

Source: https://www.globalkeysolutions.net/records/483/acuity-specialty-products-inc/851a6b5a-7231-4a02-83c4-3b0a91f5177c

> FDA 483 for Acuity Specialty Products, Inc on March 14, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Acuity Specialty Products, Inc
- Inspection Date: 2025-03-14
- Product Type: drugs
- Office Name: Philadelphia District Office
- Summary: Acuity Specialty Products, Inc. in Chambersburg, PA, was inspected and cited for numerous significant deficiencies related to its manufacturing of OTC drug products, primarily hand sanitizers. The inspection revealed widespread issues in quality control, including inadequate testing of raw materials, unvalidated test methods, and a lack of process and equipment validation. Several observations were repeat deficiencies from previous inspections, indicating persistent non-compliance with cGMP regulations.

## Related Officers

- [Evan Tong](https://www.globalkeysolutions.net/people/evan-tong/2cd81562-886c-4672-9522-a07fb1b33ef2)
- [Elena N. Thomas](https://www.globalkeysolutions.net/people/elena-n-thomas/80a975fe-c475-447e-9471-dedb68a99aae)
- [Ruben C. Quintana](https://www.globalkeysolutions.net/people/ruben-c-quintana/fbf0f0ef-eb51-4a06-a4b9-f7856fa06c58)

Company: https://www.globalkeysolutions.net/companies/acuity-specialty-products-inc/2f5726c8-d64a-425a-b0e6-b7b570ea9625

Office: https://www.globalkeysolutions.net/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8