FDA Inspection 1041122 — Techni Med, Inc.
The FDA completed an inspection of Techni Med, Inc. on Jan 26, 2018 in Aurora, IL. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI)
- End Date
- Jan 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. |