FDA Inspection 787706 — Illinois Tool Works Inc
The FDA completed an inspection of Illinois Tool Works Inc on April 30, 2012 in Olathe, KS. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 9 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- April 30, 2012
- Fiscal Year
- 2012
- 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 |
| 1358 | 21 CFR 211.100(b) | SOPs not followed / documented |
| 1976 | 21 CFR 211.182 | Specific information required in individual logs |
| 1978 | 21 CFR 211.182 | Personnel dating/signing equipment log |
| 1999 | 21 CFR 211.184(a) | Record information required |
| 2008 | 21 CFR 211.186(a) | Written procedures followed |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 4391 | 21 CFR 211.180(e)(2) | Items to cover on annual reviews |