FDA Inspection 1234178 — LCC Ltd.
The FDA completed an inspection of LCC Ltd. on March 22, 2024 in Eumseong. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 22, 2024
- Fiscal Year
- 2024
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Eumseong (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 1134 | 21 CFR 211.25(b) | Supervisor Training/Education/Experience |
| 1177 | 21 CFR 211.63 | Equipment Design, Size and Location |
| 1220 | 21 CFR 211.67(b)(3) | Cleaning SOPs/instructions |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1879 | 21 CFR 211.180(c) | Records not made readily available to FDA |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2619 | 21 CFR 211.198(b)(2) | Complaint Investigation/Follow-Up Findings |
| 3585 | 21 CFR 211.110(a) | Control procedures to monitor and validate performance |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |