FDA Inspection 866858 — Innovative Fertility Center
The FDA completed an inspection of Innovative Fertility Center on February 18, 2014 in Manhattan Beach, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 8 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 18, 2014
- Fiscal Year
- 2014
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Manhattan Beach, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12239 | 21 CFR 1271.55(b)(2) | Listing and interpretation of CD tests performed |
| 12242 | 21 CFR 1271.55(c) | Name and personal info on accompanying records |
| 12246 | 21 CFR 1271.55(d)(1)(iii) | Documentation--determination, by whom, date |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |
| 12301 | 21 CFR 1271.150(c)(1)(iii) | Ensurane of compliance |
| 12334 | 21 CFR 1271.170(c) | Trained or re-trained as necessary |
| 12492 | 21 CFR 1271.85(a) | Infection with communicable disease agents |