FDA Inspection 716355 — American Quality Manufacturing, Inc.
The FDA completed an inspection of American Quality Manufacturing, Inc. on March 29, 2011 in Cocoa, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 29, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Cocoa, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2302 | 21 CFR 820.20(e) | Quality System Procedures |
| 5007 | 21 CFR 1002.13 | Failure to submit |
| 5217 | 21 CFR 1040.20(c)(2)(iii) | Timer interval error - greater than 10 percent |