FDA Inspection 1069204 — Tai Guk Pharm Co., Ltd.
The FDA completed an inspection of Tai Guk Pharm Co., Ltd. on Oct 19, 2018 in Buyeo. 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). 8 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 19, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Buyeo (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1224 | 21 CFR 211.67(b)(6) | Cleaning SOP/inspection |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1450 | 21 CFR 211.113(a) | Procedures for non-sterile drug products |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2004 | 21 CFR 211.184(d) | Labeling: documentation of exam and review |
| 3592 | 21 CFR 211.110(c) | In-process materials characteristics testing |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |