FDA Inspection
AcquaMed Technologies IncAcquaMed Technologies Inc – FDA Inspection, May 25, 2017
Record Details
This FDA Inspection record concerns AcquaMed Technologies Inc, with an inspection on May 25, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 3bd758b7-0cbb-427d-9fb5-e6de87a403b5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1013214
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.70(a)Production processes
- 21 CFR 820.22Quality Audits - defined intervals
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Other FDA inspections of AcquaMed Technologies Inc
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 6, 2011 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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