FDA Inspection 942702 — Medical Technical Gases, Inc.
The FDA completed an inspection of Medical Technical Gases, Inc. on Aug 7, 2015 in N Billerica, MA. 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). 4 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 7, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- N Billerica, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 1215 | 21 CFR 211.67(b) | Written procedures not established/followed |
| 2026 | 21 CFR 211.192 | Quality control unit review of records |
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |