FDA Inspection 651870 — Certified Laboratories Inc.
The FDA completed an inspection of Certified Laboratories Inc. on Mar 19, 2010 in Melville, NY. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 19, 2010
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Melville, NY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |