FDA Inspection
Greco Gas, Inc.Greco Gas, Inc. – FDA Inspection, Apr 5, 2024
Record Details
This FDA Inspection record concerns Greco Gas, Inc., with an inspection on April 5, 2024, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · da40b0de-b394-4f9d-bcfe-3522dd70da6b
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1236152
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Enforcement
- Warning Letter
FDA Citations
9- 21 CFR 211.188(b)(3)Identification of each component or in-process material
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.194(a)(6)Test results, comparison with standards not included
- 21 CFR 211.68(a)Written calibration / inspection records not kept
- 21 CFR 211.165(a)Testing and release for distribution
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.22(a)Approve or reject components, products
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.84(d)(2)Reports of Analysis (Components)
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