FDA Inspection 1295928 — Identipak Inc
The FDA completed an inspection of Identipak Inc on December 18, 2025 in Mcallen, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 18, 2025
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Mcallen, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |