FDA Inspection 1195208 — Americord Registry LLC
The FDA completed an inspection of Americord Registry LLC on January 13, 2023 in Somerset, NJ. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 15 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- January 13, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Somerset, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12213 | 21 CFR 1271.47(a) | Testing, screening, donor eligibility procedures |
| 12277 | 21 CFR 1271.75(a)(1) | Risk factors, clinical evidence |
| 12285 | 21 CFR 1271.80(a) | Birth mother sample not tested |
| 12310 | 21 CFR 1271.160(a) | All core requirements covered in program |
| 12324 | 21 CFR 1271.160(b)(6) | Deviations--Investigation, documenting, trending |
| 12395 | 21 CFR 1271.225 | Verification/validation |
| 12399 | 21 CFR 1271.230(a) | Process validation procedures |
| 12436 | 21 CFR 1271.270(a) | Accurate, indelible, legible |
| 12437 | 21 CFR 1271.270(a) | Records incomplete |
| 1452 | 21 CFR 211.113(b) | Validation lacking for sterile drug products |
| 15020 | 21 CFR 1271.200(e) | Documentation of maintenance and cleaning |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4379 | 21 CFR 211.188(b)(1) | Dates not included for each significant step |