FDA Inspection 1106708 — Techni Med, Inc.
The FDA completed an inspection of Techni Med, Inc. on Oct 10, 2019 in Aurora, IL. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 10, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Aurora, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 18936 | FDCA 501(a)(2)(A) | Non-microbial contamination, production area |
| 18954 | FDCA 501(a)(2)(A) | Actionable microbial contamination, adjacent area |
| 21377 | FDCA 501(a)(2)(A) | Use of non-pharmaceutical grade components |