FDA Inspection
Perahealth IncPerahealth Inc – FDA Inspection, Jan 30, 2020
Record Details
This FDA Inspection record concerns Perahealth Inc, with an inspection on January 30, 2020, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Perahealth Inc
- Inspection Date
- January 30, 2020
- Product Type
- Devices
View Company Profile
ID · a66c0e51-3ae8-4659-a2cf-246706d7bedc
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1116338
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
14- 21 CFR 820.30(b)Design plans - Lack of or inadequate
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.170(a)Lack of or inadequate instructions
- 21 CFR 820.20(a)Management ensuring quality policy is understood
- 21 CFR 820.25(b)Training records
- 21 CFR 820.20(c)Management review - Lack of or inadequate procedures
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.40(b)Document change records, maintained.
- 21 CFR 820.200(d)Service reports
Showing 10 of 14 citations.
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.