# FDA 483 - Advance Pharmaceutical Inc - February 27, 2025

Source: https://www.keypedia.com/records/483/advance-pharmaceutical-inc/15ce1760-e850-4913-a24a-68fd99f87462

> FDA 483 for Advance Pharmaceutical Inc on February 27, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Advance Pharmaceutical Inc
- Inspection Date: 2025-02-27
- Product Type: drugs
- Office Name: New York District Office
- Summary: An FDA inspection of Advance Pharmaceutical Inc, an OTC drug manufacturer in Holtsville, NY, revealed significant deficiencies in quality unit oversight and control. Observations included failures to monitor storage temperatures for laboratory reference standards, improper handling and storage of raw materials leading to contamination risks, and inadequate storage of in-process materials in an unsecured area. These issues indicate a lack of adherence to established standards for ensuring product quality and preventing contamination.

## Related Officers

- [Tanya R. Syffrard](https://www.keypedia.com/people/tanya-r-syffrard/a78a42b3-6cef-46d9-9698-ec6082956477)
- [Luxuly Abraham](https://www.keypedia.com/people/luxuly-abraham/d33e3164-ec89-488b-bab9-a9ec30544970)

Company: https://www.keypedia.com/companies/advance-pharmaceutical-inc/a4ab6207-4e8b-464a-94b8-36c959425ac1

Office: https://www.keypedia.com/offices/new-york-district-office/9fa3d265-16ca-438d-8a6e-b47f60dc260d