FDA Inspection
R Medical Supply IncR Medical Supply Inc – FDA Inspection, Nov 17, 2016
Record Details
This FDA Inspection record concerns R Medical Supply Inc, with an inspection on November 17, 2016, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · fb7354f2-1472-4c69-956a-ad1762765095
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 993554
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
10- 21 CFR 820.20(a)Quality policy and objectives
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.20(e)Quality System Procedures
- 21 CFR 820.250(b)Sampling plans
- 21 CFR 820.40(a)Document review, approval by designated individual
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.50(b)Approval, inadequate purchasing data
- 21 CFR 820.50(b)Supplier notification of changes
- 21 CFR 820.80(b)Incoming acceptance records, documentation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of R Medical Supply Inc
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 17, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 9, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for R Medical Supply Inc
- FDA Inspection 848979 - 2013-09-17
- FDA Inspection 685638 - 2010-08-09
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.