FDA Inspection
Trim CareTrim Care – FDA Inspection, Oct 28, 2008
Record Details
This FDA Inspection record concerns Trim Care, with an inspection on October 28, 2008, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Trim Care
- Inspection Date
- October 28, 2008
- Product Type
- Drugs
View Company Profile
ID · 97b90ab5-60e0-4051-b0e6-914ba1fddc2e
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 537876
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
6- 21 CFR 50.27(a)Copy of consent form not provided
- 21 CFR 312.60FD-1572, protocol compliance
- 21 CFR 312.60Informed consent
- 21 CFR 312.62(b)Case history records- inadequate or inadequate
- 21 CFR 50.27(a)Consent form not approved/signed/dated
- 21 CFR 312.66Changes in research
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.