FDA Inspection
Cardiopulmonary Instrumentation, IncCardiopulmonary Instrumentation, Inc – FDA Inspection, Feb 1, 2011
Record Details
This FDA Inspection record concerns Cardiopulmonary Instrumentation, Inc, with an inspection on February 1, 2011, issued by the Center for Devices and Radiological Health, covering devices.
- Inspection Date
- February 1, 2011
- Product Type
- Devices
View Company Profile
ID · 3383a5be-b152-4b1a-a0b7-ca2bca2772e9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 708609
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
10- 21 CFR 806.10(a)(1)Report of risk to health
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.22Quality audits - Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.30(j)Design history file
- 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.