# FDA 483 - American Preclinical Services - April 13, 2018

Source: https://www.keypedia.com/records/483/american-preclinical-services/c29bf363-b3ea-471e-b272-ba6512766414

> FDA 483 for American Preclinical Services on April 13, 2018. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: American Preclinical Services
- Inspection Date: 2018-04-13
- Product Type: other
- Office Name: Minneapolis District Office
- Summary: American Preclinical Services, a nonclinical laboratory in Minneapolis, was cited for significant deficiencies across its Good Laboratory Practice (GLP) studies. Observations included inadequate retention and labeling of test and control articles, failures in personnel training and animal care, and critical lapses in study director oversight and quality assurance. These issues led to compromised data integrity, animal welfare concerns, and non-compliance with FDA GLP regulations.

## Related Documents

- [483 - 2011-05-04](https://www.keypedia.com/records/483/american-preclinical-services/ec109f46-f4fa-42e7-9bae-ee54d87a8bef)

## Related Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/kellie-l-thommes/255a1b92-cd56-41f5-9622-82e8a629e153)
- [investigator](https://www.keypedia.com/people/nicole-c-victoria/8c5f8060-452f-4fe5-a43f-a448ec020e60)

Company: https://www.keypedia.com/companies/american-preclinical-services/a11bdd9b-c0c8-404f-9a53-962242f99e36

Office: https://www.keypedia.com/offices/minneapolis-district-office/c79fc8dc-f884-48fc-ba80-2947f662511d