FDA Inspection 1023754 — Healthcare-Id, Inc.
The FDA completed an inspection of Healthcare-Id, Inc. on Sep 1, 2017 in Buffalo Grove, 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). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 1, 2017
- Fiscal Year
- 2017
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Buffalo Grove, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 2293 | 21 CFR 820.20(d) | Quality plan |
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |