FDA Inspection 1064033 — Woodfield Distribution, LLC
The FDA completed an inspection of Woodfield Distribution, LLC on Aug 31, 2018 in Boca Raton, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 31, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Boca Raton, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |