FDA Inspection 942541 — Aekyung Industrial Co. Ltd.
The FDA completed an inspection of Aekyung Industrial Co. Ltd. on Sep 3, 2015 in Cheongyang County. 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). 11 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 3, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Cheongyang County (Korea (the Republic of))
Citations
| ID | CFR | Description |
|---|---|---|
| 1112 | 21 CFR 211.25(a) | Training--operations, GMPs, written procedures |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1767 | 21 CFR 211.137(a) | Expiration date lacking |
| 1802 | 21 CFR 211.84(b) | Representative Samples |
| 1886 | 21 CFR 211.165(c) | Sampling and testing plans not described |
| 4325 | 21 CFR 211.110(a) | Control procedures fail to include the following |
| 4349 | 21 CFR 211.160(b)(2) | In-process samples representative, identified properly |
| 4351 | 21 CFR 211.160(b)(3) | Drug products - samples representative, identified properly |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |