FDA Inspection 941729 — Tec Laboratories, Inc.
The FDA completed an inspection of Tec Laboratories, Inc. on Aug 20, 2015 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). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 20, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Albany, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |