FDA Inspection 1164737 — BPI Labs
The FDA completed an inspection of BPI Labs on March 10, 2022 in Evanston, WY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 10, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Evanston, WY (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1395 | 21 CFR 211.103 | Actual vs. theoretical yields not determined |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1540 | 21 CFR 211.125(a) | Strict control not exercised over labeling issued |
| 1803 | 21 CFR 211.84(b) | Representative Samples Criteria |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 1918 | 21 CFR 211.166(a)(2) | Stability sample storage conditions described |
| 1942 | 21 CFR 211.180(e) | Records reviewed annually |
| 2014 | 21 CFR 211.188(b)(2) | Identification of Equipment and Lines |