# FDA 483 - Ampharmco LLC - March 27, 2019

Source: https://www.keypedia.com/records/483/ampharmco-llc/f13649f8-5e22-404d-b4a1-c475d25d3bbe

> FDA 483 for Ampharmco LLC on March 27, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ampharmco LLC
- Inspection Date: 2019-03-27
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of American Pharmaceuticals & Cosmetics, Inc. in Fort Worth, TX, revealed significant deficiencies in equipment cleaning validation for animal drug products and inadequate maintenance of sterilization equipment. These issues raise concerns about the firm's ability to ensure product quality and sterility assurance for released drug products.

## Related Officers

- [Investigator](https://www.keypedia.com/people/patty-p-kaewussdangkul/1f0961fc-216e-4580-830a-56a76c0e7cea)
- [Strategic Accounts Operations Manager / Account Executive](https://www.keypedia.com/people/aqualia-l-nelson/8ceeb15a-29d4-4924-aca0-0a7c86761a82)

Company: https://www.keypedia.com/companies/ampharmco-llc/e089bf87-2765-458c-9220-4447df7716f3

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9