FDA Inspection
ASO LLCASO LLC – FDA Inspection, Oct 5, 2012
Record Details
This FDA Inspection record concerns ASO LLC, with an inspection on October 5, 2012, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- ASO LLC
- Inspection Date
- October 5, 2012
- Product Type
- Devices
View Company Profile
ID · d37d8c6d-fe20-477a-91fd-d0a63fa37745
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 802345
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 820.100(b)Documentation
- 21 CFR 820.198(d)Records of MDR Investigation
- 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
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Other FDA inspections of ASO LLC
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 12, 2018 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for ASO LLC
- FDA Inspection 1067557 - 2018-09-12
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