# FDA 483 - Ampak Chemicals Incorporated - April 09, 2021

Source: https://www.globalkeysolutions.net/records/483/ampak-chemicals-incorporated/633f733b-d261-491f-a5f0-8a5f58b55cf5

> FDA 483 for Ampak Chemicals Incorporated on April 09, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ampak Chemicals Incorporated
- Inspection Date: 2021-04-09
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Ampak Chemicals Incorporated, an OTC drug manufacturer in Carson, CA, was inspected and found to have severe deficiencies across its manufacturing operations for bulk hand sanitizer. The firm lacks a functional quality control unit, written procedures for material control, production, process controls, and laboratory testing, and fails to maintain its facility and calibrate critical equipment. These issues indicate a fundamental absence of Good Manufacturing Practices.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/heidy-c-perales/fdf71c74-8cb7-41b5-9070-6b8eb11cb404)
- [Stephanie A. Slater](https://www.globalkeysolutions.net/people/stephanie-a-slater/f356e65c-3398-4688-8b86-4dcd4b9ae83b)

Company: https://www.globalkeysolutions.net/companies/ampak-chemicals-incorporated/77790262-fb37-4bd6-8aa6-933fb538c58e

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6