FDA Inspection 1034237 — SC Johnson Professional USA, Inc.
The FDA completed an inspection of SC Johnson Professional USA, Inc. on December 7, 2017 in Stanley, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 7, 2017
- Fiscal Year
- 2018
- 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 |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 2017 | 21 CFR 211.188(b)(5) | In-Process and Laboratory Control Results |
| 2401 | 21 CFR 211.194(a)(4) | Complete Test Data |
| 2402 | 21 CFR 211.194(a)(5) | Testing Calculations |
| 3567 | 21 CFR 211.84(d)(2) | Component identification test |
| 3570 | 21 CFR 211.100(a) | Approval and review of procedures |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4412 | 21 CFR 211.194(a)(7) | Signatures and dates--person who performs test |
| 4576 | 21 CFR 211.192 | No written record of investigation |