FDA Inspection 637094 — Thornton Industries, Inc.
The FDA completed an inspection of Thornton Industries, Inc. on December 18, 2009 in Morris, IL. 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
- December 18, 2009
- Fiscal Year
- 2010
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Morris, IL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1105 | 21 CFR 211.22(d) | Procedures not in writing, fully followed |
| 1261 | 21 CFR 211.68(a) | Written calibration / inspection records not kept |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1883 | 21 CFR 211.165(a) | Testing and release for distribution |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4366 | 21 CFR 211.188(a) | Accurate reproduction included |