FDA Inspection 987239 — SC Johnson Professional USA, Inc.
The FDA completed an inspection of SC Johnson Professional USA, Inc. on September 2, 2016 in Stanley, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 15 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 2, 2016
- Fiscal Year
- 2016
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Stanley, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 1227 | 21 CFR 211.67(c) | Cleaning/maintenance records not kept |
| 1256 | 21 CFR 211.68(b) | Backup file not maintained |
| 1454 | 21 CFR 211.115(a) | Reprocessing procedures not written or followed |
| 1833 | 21 CFR 211.84(d)(1) | Identity Testing of Each Component |
| 2015 | 21 CFR 211.188(b)(3) | Identification of Components and In-Process Materials |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 3567 | 21 CFR 211.84(d)(2) | Component identification test |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 4412 | 21 CFR 211.194(a)(7) | Signatures and dates--person who performs test |