FDA Inspection 756378 — Technical Gas Products, Inc.
The FDA completed an inspection of Technical Gas Products, Inc. on Dec 8, 2011 in Muncie, IN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 8, 2011
- Fiscal Year
- 2012
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Muncie, IN (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 |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 3603 | 21 CFR 211.160(b) | Scientifically sound laboratory controls |
| 4306 | 21 CFR 211.80(a) | Written Procedures Not Followed |