FDA Inspection
H & H MedicalH & H Medical – FDA Inspection, Jan 10, 2012
Record Details
This FDA Inspection record concerns H & H Medical, with an inspection on January 10, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- H & H Medical
- Inspection Date
- January 10, 2012
- Product Type
- Devices
View Company Profile
ID · 78be4e71-e01f-4dac-9449-b6502665fc65
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 760033
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 821.25(a)Written tracking program
- 21 CFR 820.20(d)Quality plan
- 21 CFR 820.40Lack of procedures, or not maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.75(a)Documentation
- 21 CFR 803.17Lack of Written MDR Procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of H & H Medical
4| Date | Classification | Office | Project area |
|---|---|---|---|
| September 16, 2021 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 26, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 25, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 17, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for H & H Medical
- FDA Inspection 1156360 - 2021-09-16
- FDA Inspection 1031635 - 2017-10-26
- FDA Inspection 932053 - 2015-06-25
- FDA Inspection 807415 - 2012-10-17
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.