FDA Inspection
American Preclinical ServicesAmerican Preclinical Services – FDA Inspection, Apr 13, 2018
Record Details
This FDA Inspection record concerns American Preclinical Services, with an inspection on April 13, 2018, issued by the Minneapolis District Office, covering medical devices & rad health.
- Inspection Date
- April 13, 2018
- Product Type
- Medical Devices & Rad Health
View Company Profile
ID · e258f14e-6044-401f-afa2-7fb55ad5e020
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1048064
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
4- 21 CFR 58.105(d)Test article: reserve sample retention
- 21 CFR 58.31(f)Management: personnel understand their functions
- 21 CFR 58.33(e)Study director: follow GLP regulations
- 21 CFR 58.35(a)QAU: monitor facilities, etc.
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.