FDA Inspection 1155897 — Uriel Pharmacy, Inc
The FDA completed an inspection of Uriel Pharmacy, Inc on November 2, 2021 in East Troy, WI. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 13 citations were issued during this inspection. Product area: Food/Cosmetics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- November 2, 2021
- Fiscal Year
- 2022
- Product Type
- Food/Cosmetics
- Project Area
- Food Composition, Standards, Labeling and Econ
- Location
- East Troy, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15492 | 21 CFR 111.25(a) | Procedures - calibrating instruments |
| 15533 | 21 CFR 111.255(c) | Batch record - follow master |
| 15543 | 21 CFR 111.260(c) | Batch record - date, time; maintenance |
| 15554 | 21 CFR 111.260(j)(2)(ii) | Batch record - initials; verifying weight |
| 15712 | 21 CFR 111.325(b)(2)(ii) | Records - document; results |
| 15748 | 21 CFR 111.210(f) | Master manufacturing record theoretical and expected yield |
| 15753 | 21 CFR 111.210(b) | Master manufacturing record - list components |
| 15759 | 21 CFR 111.205(b)(2) | Master manufacturing record - controls, procedures |
| 15829 | 21 CFR 111.70(b)(1) | Specifications - component identity |
| 15830 | 21 CFR 111.70(b)(2) | Specifications-component purity, strength, composition |
| 15831 | 21 CFR 111.70(b)(3) | Specifications - contamination limits |
| 15839 | 21 CFR 111.70(e) | Specifications - identity, purity, strength, composition |
| 15882 | 21 CFR 111.75(h) | Tests, examinations - scientifically valid |