FDA Inspection 753058 — Tec Laboratories, Inc.
The FDA completed an inspection of Tec Laboratories, Inc. on Oct 28, 2011 in Albany, OR. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 28, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Albany, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1159 | 21 CFR 211.28(a) | Clothing appropriate for duties performed |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1790 | 21 CFR 211.80(b) | Handling and Storage to Prevent Contamination |