FDA Inspection 1223645 — GLOBAL WIDGET LLC
The FDA completed an inspection of GLOBAL WIDGET LLC on November 17, 2023 in Tampa, FL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- November 17, 2023
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Tampa, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 3616 | 21 CFR 211.165(d) | Acceptance criteria for sampling & testing |