FDA Inspection 1102954 — Globus Medical, Inc.
The FDA completed an inspection of Globus Medical, Inc. on Sep 27, 2019 in West Norriton, 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). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 27, 2019
- Fiscal Year
- 2019
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- West Norriton, PA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12416 | 21 CFR 1271.260(e) | Storage temperatures recorded, maintained |
| 12432 | 21 CFR 1271.265(e) | Documentation elements for activities |
| 12437 | 21 CFR 1271.270(a) | Records incomplete |
| 14722 | 21 CFR 820.40 | Procedures not adequately established or maintained |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3671 | 21 CFR 820.25(a) | Personnel |