FDA Inspection 661027 — Laurel Fertility Care, A Professional Medical Corporation
The FDA completed an inspection of Laurel Fertility Care, A Professional Medical Corporation on May 6, 2010 in San Francisco, 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
- May 6, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- San Francisco, CA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12221 | 21 CFR 1271.47(a) | Procedures for all other requirements |
| 12225 | 21 CFR 1271.47(d) | Departures: recording and justifying |
| 12230 | 21 CFR 1271.50(a) | Responsible person to determine, document |
| 12286 | 21 CFR 1271.80(b) | Specimen collections not timely |
| 12301 | 21 CFR 1271.150(c)(1)(iii) | Ensurane of compliance |