FDA Inspection 773972 — LG Household & Health Care Ltd.
The FDA completed an inspection of LG Household & Health Care Ltd. on Feb 24, 2012 in Cheongju. 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). 9 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 24, 2012
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cheongju (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1975 | 21 CFR 211.182 | Written records kept in individual logs |
| 2033 | 21 CFR 211.194(c) | Testing and standardization of standards et. al. |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 4309 | 21 CFR 211.84(c)(2) | Containers sampled so as to prevent contamination |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |
| 4406 | 21 CFR 211.194(a)(2) | Suitability of testing methods verified |