FDA Inspection 822299 — Aesculap Inc
The FDA completed an inspection of Aesculap Inc on Mar 12, 2013 in Center Valley, PA. 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). 2 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Mar 12, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Bioresearch Monitoring
- Location
- Center Valley, PA (United States)
Additional Details
Sponsor, Contract Research Organization
Citations
| ID | CFR | Description |
|---|---|---|
| 2993 | 21 CFR 812.140(b)(2) | Sponsor device disposition records inadequate |
| 2994 | 21 CFR 812.140(b)(3) | Sponsor records of investigator agreements inadequate |