FDA Inspection 1106708 — Techni Med, Inc. dba The Compounder
The FDA completed an inspection of Techni Med, Inc. dba The Compounder on October 10, 2019 in Aurora, IL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- October 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 |