FDA Inspection 1140292 — SURGENEX LLC
The FDA completed an inspection of SURGENEX LLC on April 16, 2021 in Scottsdale, AZ. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 12 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 16, 2021
- Fiscal Year
- 2021
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Scottsdale, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1194 | 21 CFR 211.42(c) | Defined areas of adequate size for operations |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12371 | 21 CFR 1271.200(a) | Cleaned, sanitized per established schedules |
| 12398 | 21 CFR 1271.230(a) | Validation & approval--established procedures |
| 12402 | 21 CFR 1271.230(c) | Changes to validated process |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2027 | 21 CFR 211.192 | Investigations of discrepancies, failures |
| 3605 | 21 CFR 211.160(b)(1) | Specification description of sample/testing |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |