# FDA 483 - American Spraytech LLC - January 24, 2025

Source: https://www.globalkeysolutions.net/records/483/american-spraytech-llc/9a6d11a4-da1f-4672-b4c4-c2560efa78fa

> FDA 483 for American Spraytech LLC on January 24, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American Spraytech LLC
- Inspection Date: 2025-01-24
- Product Type: drugs
- Office Name: New Jersey District Office
- Summary: American Spraytech LLC, a drug manufacturer in Branchburg, NJ, received a Form 483 with three observations. The inspection revealed significant deficiencies in equipment cleaning and maintenance, including leaks and stagnant liquids, and a failure to properly investigate quality events like mold growth. Additionally, the firm lacked adequate controls for electronic data integrity, specifically regarding the review of raw data, audit trails, and chromatography test injections.

## Related Documents

- [483 - 2024-04-11](https://www.globalkeysolutions.net/records/483/american-spraytech-llc/c667e876-880d-43c4-93b0-b1e73f9365e7)

## Related Officers

- [Claude Noel](https://www.globalkeysolutions.net/people/claude-noel/afd7b4dd-50c8-4532-b9b0-73a02be0e005)
- [Claude Noel Y. Zanetsie](https://www.globalkeysolutions.net/people/claude-noel-y-zanetsie/d2341300-2c9d-4d22-bb70-5b442d4e3b70)
- [issuing_officer](https://www.globalkeysolutions.net/people/catherine-o-lamptey/9ddfa564-70b7-4a8b-9209-9d21205ebf60)
- [Adetutu M. Gidado](https://www.globalkeysolutions.net/people/adetutu-m-gidado/6c4e8cf3-0eea-4903-9ca5-e8e2d683621d)

Company: https://www.globalkeysolutions.net/companies/american-spraytech-llc/fc33eb75-e75e-42fd-b6a5-a042d486fb23

Office: https://www.globalkeysolutions.net/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248