FDA Inspection
Bosque Custom Designs, IncBosque Custom Designs, Inc – FDA Inspection, May 24, 2011
Record Details
This FDA Inspection record concerns Bosque Custom Designs, Inc, with an inspection on May 24, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Bosque Custom Designs, Inc
- Inspection Date
- May 24, 2011
- Product Type
- Devices
View Company Profile
ID · 2825157b-a625-404b-947e-cbd2dadca523
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 727268
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.22Quality Audits - defined intervals
- 21 CFR 820.184DHR content
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.