FDA Inspection
AcquaMed Technologies IncAcquaMed Technologies Inc – FDA Inspection, Jun 6, 2011
Record Details
This FDA Inspection record concerns AcquaMed Technologies Inc, with an inspection on June 6, 2011, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- AcquaMed Technologies Inc
- Inspection Date
- June 6, 2011
- Product Type
- Drugs
View Company Profile
ID · c54d10be-d26d-41f6-b157-c292d5b259c1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 731750
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
13- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.100(b)Documentation
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 820.20(c)Management review - defined interval, sufficient frequency
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.250(a)Statistical techniques - Lack of or inadequate procedures
- 21 CFR 820.22Quality Audit/Reaudit - conducted
- 21 CFR 820.86Acceptance status
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Other FDA inspections of AcquaMed Technologies Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 25, 2017 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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