FDA Inspection 1087396 — Spencer Specialty Products Inc
The FDA completed an inspection of Spencer Specialty Products Inc on April 25, 2019 in Boise, ID. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 25, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Boise, ID (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1420 | 21 CFR 211.42(c)(9) | Control / Lab Operations Area |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1770 | 21 CFR 211.137(d) | Expiration date location on labeling |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 21296 | 21 CFR 211.186(a) | Master production and control records, batch uniformity |
| 3567 | 21 CFR 211.84(d)(2) | Component identification test |
| 4325 | 21 CFR 211.110(a) | Control procedures fail to include the following |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |