# FDA 483 - Mars Fishcare North America, Inc. - April 07, 2023

Source: https://www.keypedia.com/records/483/mars-fishcare-north-america-inc/2fef26d4-999e-4944-800c-d02e6c28cd6d

> FDA 483 for Mars Fishcare North America, Inc. on April 07, 2023. Product: veterinary. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Mars Fishcare North America, Inc.
- Inspection Date: 2023-04-07
- Product Type: veterinary
- Office Name: Philadelphia District Office
- Summary: Mars Fishcare North America, Inc. in Chalfont, PA, a veterinary drug manufacturer, was cited for six observations during an FDA inspection. The inspection revealed significant deficiencies in laboratory controls, including inadequate OOS investigations, insufficient active ingredient testing, and unqualified reference standards. Additionally, issues were noted with equipment design, cleaning validation, and computer system audit trail reviews, indicating a broad lack of adherence to GMP regulations.

## Related Officers

- [ Drug Investigator](https://www.keypedia.com/people/tekalign-wondimu/3b80e5c8-4062-4e1d-8ddd-b1afa2616dec)

Company: https://www.keypedia.com/companies/mars-fishcare-north-america-inc/67c95ddb-eb24-4fa5-8a56-a33000a00c24

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8