FDA Inspection 1032092 — Cosmax Bio, Inc.
The FDA completed an inspection of Cosmax Bio, Inc. on November 10, 2017 in Jecheon. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 12 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- November 10, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Jecheon (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 1890 | 21 CFR 211.165(e) | Test methods |
| 1943 | 21 CFR 211.180(e)(1) | Review of representative number of batches |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2031 | 21 CFR 211.194(a) | Complete test data included in records |
| 2405 | 21 CFR 211.194(a)(7) | Identification of Person Performing the Testing |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4406 | 21 CFR 211.194(a)(2) | Suitability of testing methods verified |