FDA Inspection 1041122 — Techni Med, Inc. dba The Compounder
The FDA completed an inspection of Techni Med, Inc. dba The Compounder on January 26, 2018 in Aurora, IL. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 26, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Aurora, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 18937 | FDCA 501(a)(2)(A) | Beta-lactam drugs, inadequate sanitation |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 4357 | 21 CFR 211.166(a) | Results not used for expiration dates, storage cond. |