FDA Inspection
GERI-GENTLE CORPORATIONGERI-GENTLE CORPORATION – FDA Inspection, Dec 4, 2017
Record Details
This FDA Inspection record concerns GERI-GENTLE CORPORATION, with an inspection on December 4, 2017, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 9151ad5b-ecf3-45ba-b588-75aa4ac504e1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1033906
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.150Lack of or inadequate procedures for storage.
- 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.