FDA Inspection 1014307 — Wedgewood Connect, LLC
The FDA completed an inspection of Wedgewood Connect, LLC on Jun 15, 2017 in San Jose, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 15, 2017
- Fiscal Year
- 2017
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- San Jose, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 2028 | 21 CFR 211.192 | Extent of discrepancy, failure investigations |