FDA Inspection 638727 — Great Lakes Orthopedics, LLC
The FDA completed an inspection of Great Lakes Orthopedics, LLC on Jan 5, 2010 in Brookfield, WI. 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 5, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Brookfield, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12324 | 21 CFR 1271.160(b)(6) | Deviations--Investigation, documenting, trending |
| 12326 | 21 CFR 1271.160(c) | Quality audits performed periodically |
| 12373 | 21 CFR 1271.200(d) | Inspected routinely |
| 15020 | 21 CFR 1271.200(e) | Documentation of maintenance and cleaning |