FDA Inspection 567373 — Parker Laboratories, Inc.
The FDA completed an inspection of Parker Laboratories, Inc. on February 19, 2009 in Fairfield, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 19, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Fairfield, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 4167 | 21 CFR 820.70(g) | Specified requirements |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |