# FDA 483 - Nitro Quimica Corporation dba Alchemix A Nitro Quimica Corporation - February 21, 2025

Source: https://www.globalkeysolutions.net/records/483/nitro-quimica-corporation-dba-alchemix-a-nitro-quimica-corporation/af33c5e0-81c8-4ed3-bc50-2095c270b01c

> FDA 483 for Nitro Quimica Corporation dba Alchemix A Nitro Quimica Corporation on February 21, 2025. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Nitro Quimica Corporation dba Alchemix A Nitro Quimica Corporation
- Inspection Date: 2025-02-21
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Nitro Corporation, an OTC drug manufacturer in College Park, GA, was inspected by the FDA, revealing significant deficiencies across multiple areas. The inspection found issues with quality control, unwritten reprocessing procedures, inadequate storage conditions, and failures in equipment cleaning and qualification. These observations indicate a lack of adherence to good manufacturing practices, leading to product quality problems and customer complaints.

## Related Documents

- [EIR - 2019-02-14](https://www.globalkeysolutions.net/records/eir/nitro-quimica-corporation-dba-alchemix-a-nitro-quimica-corporation/06ffd866-0a0e-42b0-bb6b-8936e614d8d2)
- [EIR - 2019-02-14](https://www.globalkeysolutions.net/records/eir/nitro-quimica-corporation-dba-alchemix-a-nitro-quimica-corporation/b873052f-4841-426a-837e-67e5b2ae5e63)

## Related Officers

- [Dorothy P. Kramer](https://www.globalkeysolutions.net/people/dorothy-p-kramer/12e3c8b6-6359-43cc-96fd-ba2097225e3d)

Company: https://www.globalkeysolutions.net/companies/nitro-quimica-corporation-dba-alchemix-a-nitro-quimica-corporation/a2c8391c-ef9e-4769-a7fc-5a0c0431baf1

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7