FDA Inspection 1166556 — Illinois Tool Works Inc
The FDA completed an inspection of Illinois Tool Works Inc on April 1, 2022 in Olathe, KS. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 6 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 1, 2022
- Fiscal Year
- 2022
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Olathe, KS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1270 | 21 CFR 211.68(b) | input/output verification |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1545 | 21 CFR 211.125(c) | Label reconciliation discrepancies evaluation/investigation |
| 1885 | 21 CFR 211.165(b) | Microbiological testing |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |