FDA Inspection 1171491 — Integra LifeSciences Sales LLC
The FDA completed an inspection of Integra LifeSciences Sales LLC on May 26, 2022 in Cordova, TN. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- May 26, 2022
- Fiscal Year
- 2022
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Cordova, TN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12337 | 21 CFR 1271.180(a) | Design adequate to bar spread of CD's |
| 12435 | 21 CFR 1271.270(a) | Records maintained concurrently |