FDA Inspection 1099983 — Tec Laboratories, Inc.
The FDA completed an inspection of Tec Laboratories, Inc. on August 9, 2019 in Albany, OR. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 7 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- August 9, 2019
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Unapproved and Misbranded Drugs
- Location
- Albany, OR (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1263 | 21 CFR 211.68(b) | Computer control of master formula records |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1413 | 21 CFR 211.42(c)(5) | Mfg / Processing Operations Area |
| 3571 | 21 CFR 211.100(a) | Changes to Procedures Not Reviewed, Approved |