FDA Inspection 902151 — Wedgewood Connect, LLC
The FDA completed an inspection of Wedgewood Connect, LLC on October 7, 2014 in San Jose, CA. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 7, 2014
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- San Jose, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1454 | 21 CFR 211.115(a) | Reprocessing procedures not written or followed |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |