FDA Inspection
SteriGear, LLCSteriGear, LLC – FDA Inspection, May 9, 2014
Record Details
This FDA Inspection record concerns SteriGear, LLC, with an inspection on May 9, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- SteriGear, LLC
- Inspection Date
- May 9, 2014
- Product Type
- Devices
View Company Profile
ID · 2f6e6f99-a566-4f53-9bc7-5d7fee722ca9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 878262
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
8- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 806.10(b)Time to report - 10 days
- 21 CFR 820.30(f)Design verification - output does not meet input requirement
- 21 CFR 820.50(a)(1)Evaluation and Selection, Suppliers, Contractors, etc.
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.30(g)Design Validation - Risk analysis not performed/inadequate
- 21 CFR 820.50(a)(1)Documented evaluation
- 21 CFR 820.50(b)Supplier notification of changes
Full citation text and observation details available on the Dashboard.
Other FDA inspections of SteriGear, LLC
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 22, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 6, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 17, 2011 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for SteriGear, LLC
- FDA Inspection 1200541 - 2023-03-22
- FDA Inspection 1004659 - 2017-03-06
- FDA Inspection 714471 - 2011-03-17
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