FDA Inspection 698855 — Sunrise Medical Laboratories, Inc.
The FDA completed an inspection of Sunrise Medical Laboratories, Inc. on November 19, 2010 in Hicksville, NY. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 19, 2010
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Hicksville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12288 | 21 CFR 1271.80(c) | Manufacturer instructions not followed |
| 12435 | 21 CFR 1271.270(a) | Records maintained concurrently |