FDA Inspection 1019021 — Florida Lions Eye Bank, Inc.
The FDA completed an inspection of Florida Lions Eye Bank, Inc. on July 21, 2017 in Miami, 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
- July 21, 2017
- Fiscal Year
- 2017
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12248 | 21 CFR 1271.55(d)(2) | Information, English or translated-authenticity |
| 12364 | 21 CFR 1271.195(c) | Monitoring-microorganisms where appropriate |
| 12371 | 21 CFR 1271.200(a) | Cleaned, sanitized per established schedules |
| 12400 | 21 CFR 1271.230(a) | Documented, dated, signed |
| 12417 | 21 CFR 1271.260(e) | Periodic review of temperatures |
| 12474 | 21 CFR 1271.350(b)(2) | Content of deviation reports |