FDA Inspection 713750 — American Homecare Specialists, Inc.
The FDA completed an inspection of American Homecare Specialists, Inc. on March 11, 2011 in Woburn, MA. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- March 11, 2011
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Woburn, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1797 | 21 CFR 211.82(a) | Examination on receipt, before acceptance |
| 1844 | 21 CFR 211.84(d)(2) | Establish reliability of supplier's C of A |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |
| 4355 | 21 CFR 211.165(c) | Sampling and testing plans not followed |