FDA Inspection 916518 — Micra Biotechnologies, Inc.
The FDA completed an inspection of Micra Biotechnologies, Inc. on March 10, 2015 in River Edge, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 10, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- River Edge, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |
| 4405 | 21 CFR 211.194(a)(2) | Statement of methods and data |
| 4407 | 21 CFR 211.194(a)(2) | Reference and method not stated |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |