FDA Inspection
Respiratory Delivery SystemsRespiratory Delivery Systems – FDA Inspection, Jun 16, 2016
Record Details
This FDA Inspection record concerns Respiratory Delivery Systems, with an inspection on June 16, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Respiratory Delivery Systems
- Inspection Date
- June 16, 2016
- Product Type
- Devices
View Company Profile
ID · 1ddd43b9-0d28-4d64-9293-81a75b76cd31
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 976703
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50(a)Evaluation of suppliers, contractors, etc., requirements
- 21 CFR 803.17Lack of Written MDR Procedures
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.