FDA Inspection
Aerus, LlcAerus, Llc – FDA Inspection, Jun 14, 2010
Record Details
This FDA Inspection record concerns Aerus, Llc, with an inspection on June 14, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Aerus, Llc
- Inspection Date
- June 14, 2010
- Product Type
- Devices
View Company Profile
ID · 9b2ef2fa-eea1-4921-be56-9f74679dee89
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 664199
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
8- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.198(a)Complaints
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 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 820.50(a)(2)Supplier oversight
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