FDA Inspection 819387 — Newport Beach IVF, LLC
The FDA completed an inspection of Newport Beach IVF, LLC on February 26, 2013 in Newport Beach, CA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- February 26, 2013
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Newport Beach, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12247 | 21 CFR 1271.55(d)(2) | Accurate, indelible, legible |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |
| 12290 | 21 CFR 1271.80(d)(1) | Reactive tests--not determined ineligible |