FDA Inspection 631624 — Tenco Assemblies, Inc.
The FDA completed an inspection of Tenco Assemblies, Inc. on Nov 25, 2009 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
- Nov 25, 2009
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Morrisville, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 4341 | 21 CFR 211.142(a) | Quarantine - written procedures |