FDA Inspection 1198027 — Neobiosis LLC
The FDA completed an inspection of Neobiosis LLC on February 21, 2023 in Gainesville, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- February 21, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Gainesville, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1434 | 21 CFR 211.42(c)(10)(iv) | Environmental Monitoring System |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1868 | 21 CFR 211.94(b) | Protection from external factors |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 4359 | 21 CFR 211.170(b)(1) | Retention time of reserve samples, in general |