FDA Inspection 1245718 — Tenco Assemblies, Inc.
The FDA completed an inspection of Tenco Assemblies, Inc. on Aug 7, 2024 in Morrisville, PA. 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 7, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Morrisville, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 3629 | 21 CFR 211.170(b) | Reserve samples identified, representative, stored |