FDA Inspection 579982 — ZimVie US Corp LLC
The FDA completed an inspection of ZimVie US Corp LLC on May 1, 2009 in Palm Beach Gardens, FL. 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: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 1, 2009
- Fiscal Year
- 2009
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Palm Beach Gardens, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2556 | 21 CFR 820.30(c) | Incomplete, ambiguous, conflicting design requirements |
| 3233 | 21 CFR 820.72(a) | Calibration, Inspection, etc. Procedures Lack of or Inadequ |
| 3380 | 21 CFR 820.198(e)(6) | Results of investigation |
| 3692 | 21 CFR 820.100(a)(4) | CAPA verification/validation of corrective/preventive action |
| 4191 | 21 CFR 806.10(a)(1) | Report of risk to health |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |