FDA Inspection 583050 — Alera Technologies, Inc.
The FDA completed an inspection of Alera Technologies, Inc. on May 20, 2009 in Salt Lake City, UT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 20, 2009
- Fiscal Year
- 2009
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Salt Lake City, UT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1598 | 21 CFR 110.37(b)(4) | Drainage |
| 9931 | 21 CFR 120.6(b) | Sanitation monitoring |