FDA Inspection 1066558 — Kumho Dental Pharm Co., Ltd.
The FDA completed an inspection of Kumho Dental Pharm Co., Ltd. on Sep 13, 2018 in Geumcheon. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 13, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Geumcheon (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1256 | 21 CFR 211.68(b) | Backup file not maintained |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 3547 | 21 CFR 211.46(b) | Equipment for Environmental Control |
| 3559 | 21 CFR 211.56(a) | Sanitation--buildings not clean, free of infestation |
| 3561 | 21 CFR 211.56(b) | Written sanitation procedures lacking |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |
| 4378 | 21 CFR 211.188(b)(2) | Identity of major equipment and lines used |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |