FDA Inspection 1013214 — AcquaMed Technologies Inc
The FDA completed an inspection of AcquaMed Technologies Inc on May 25, 2017 in Oswego, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 25, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Oswego, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 4059 | 21 CFR 820.22 | Quality Audits - defined intervals |
| 537 | 21 CFR 820.70(a) | Production processes |