FDA Inspection
Reproductive Health SpecialistsReproductive Health Specialists – FDA Inspection, Mar 5, 2014
Record Details
This FDA Inspection record concerns Reproductive Health Specialists, with an inspection on March 5, 2014, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- March 5, 2014
- Product Type
- Biologics
View Company Profile
ID · 8c849195-764c-4943-93a1-5c1fc19eb7b9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 868839
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
2- 21 CFR 1271.80(c)Kits not FDA approved, specifically labeled
- 21 CFR 1271.85(a)Infection with communicable disease agents
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.