FDA Inspection
Medical Technical Gases, Inc.Medical Technical Gases, Inc. – FDA Inspection, Jul 8, 2022
Record Details
This FDA Inspection record concerns Medical Technical Gases, Inc., with an inspection on July 8, 2022, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- July 8, 2022
- Product Type
- Drugs
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ID · 45537bcc-0e81-43c6-a33b-c686395b1b0f
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1174079
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
11- 21 CFR 211.188(b)(8)Labeling control records including specimens or copies
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.68(b)Backup file not maintained
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.166(a)Lack of written stability program
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Medical Technical Gases, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 12, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 7, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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