FDA Inspection 1149863 — Cord For Life, Inc.
The FDA completed an inspection of Cord For Life, Inc. on Aug 26, 2021 in Altamonte Springs, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 26, 2021
- Fiscal Year
- 2021
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Altamonte Springs, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 1914 | 21 CFR 211.166(a) | Lack of written stability program |
| 2011 | 21 CFR 211.188(a) | Accurate reproduction |
| 4576 | 21 CFR 211.192 | No written record of investigation |