FDA Inspection 969519 — SV Labs Prescott Corporation
The FDA completed an inspection of SV Labs Prescott Corporation on March 10, 2016 in Prescott, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 14 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 10, 2016
- Fiscal Year
- 2016
- Product Type
- Food/Cosmetics
- Project Area
- Colors and Cosmetics Technology
- Location
- Prescott, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1876 | 21 CFR 211.180(b) | Record maintenance 1 year (except exempt OTC) |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 1917 | 21 CFR 211.166(a)(1) | Sample size - test intervals |
| 1922 | 21 CFR 211.166(a)(4) | Testing in same container - closure system |
| 1926 | 21 CFR 211.166(b) | Adequate number of batches on stability |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4401 | 21 CFR 211.186(b)(9) | Complete instructions, procedures, specifications et. al. |