1236152

Greco Gas, Inc. — FEI 2516287

Inspection Details

Classification
Official Action Indicated (OAI) (OAI)
End Date
April 5, 2024
Fiscal Year
2024
Product Type
Drugs
Project Area
Drug Quality Assurance
Location
Tarentum, PA (United States)

Citations

IDCFRDescription
104921 CFR 211.22(a)Approve or reject components, products
113321 CFR 211.25(a)GMP Training Frequency
126121 CFR 211.68(a)Written calibration / inspection records not kept
188321 CFR 211.165(a)Testing and release for distribution
202721 CFR 211.192Investigations of discrepancies, failures
431421 CFR 211.84(d)(2)Reports of Analysis (Components)
435221 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
437721 CFR 211.188(b)(3)Identification of each component or in-process material
441121 CFR 211.194(a)(6)Test results, comparison with standards not included