FDA Inspection 773172 — Ology Bioservices, Inc.
The FDA completed an inspection of Ology Bioservices, Inc. on Mar 9, 2012 in Alachua, FL. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Mar 9, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Alachua, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 14720 | 21 CFR 820.50(a)(3) | Acceptable supplier records, inadequate records |
| 3198 | 21 CFR 820.40(b) | Document changes, review and approval, communication |