FDA Inspection 738720 — California Fertility Partners, A Medical Group, Professional Corporations
The FDA completed an inspection of California Fertility Partners, A Medical Group, Professional Corporations on August 5, 2011 in Los Angeles, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 5, 2011
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Los Angeles, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12222 | 21 CFR 1271.47(a) | Design of procedures to ensure compliance |
| 12223 | 21 CFR 1271.47(b) | Review and approval of procedures |
| 12239 | 21 CFR 1271.55(b)(2) | Listing and interpretation of CD tests performed |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |
| 12282 | 21 CFR 1271.75(d) | Donors with risks not determined ineligible |