FDA Inspection 805572 — Central Coast Multispecialty Medical Group, Inc.
The FDA completed an inspection of Central Coast Multispecialty Medical Group, Inc. on Nov 2, 2012 in Monterey, CA. 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 2, 2012
- Fiscal Year
- 2013
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Monterey, 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 |
| 12282 | 21 CFR 1271.75(d) | Donors with risks not determined ineligible |
| 12283 | 21 CFR 1271.75(e) | Abbreviated procedure |