FDA Inspection 1239104 — Continental Services Group, Inc.
The FDA completed an inspection of Continental Services Group, Inc. on May 21, 2024 in Miami, FL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 11 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 21, 2024
- Fiscal Year
- 2024
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 142 | 21 CFR 606.140(a) | Establishment of spec., standards, and test procedures |
| 144 | 21 CFR 606.140(c) | Adequate identification and handling of test samples |
| 155 | 21 CFR 606.160(b) | Required records |
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 18116 | 21 CFR 630.30(a)(3) | Donor medical history |
| 35 | 21 CFR 606.40 | Clean & orderly |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9044 | 21 CFR 600.10(b) | Personnel capabilities |
| 9256 | 21 CFR 610.41 | Donor Deferral |
| 9270 | 21 CFR 610.40(h)(2)(ii) | Labeling of reactive units, units from deferred donors |
| 98 | 21 CFR 606.100(c) | Thorough investigations |