FDA Inspection
Monroe Transfilling, LLCMonroe Transfilling, LLC – FDA Inspection, Jun 2, 2015
Record Details
This FDA Inspection record concerns Monroe Transfilling, LLC, with an inspection on June 2, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Monroe Transfilling, LLC
- Inspection Date
- June 2, 2015
- Product Type
- Drugs
View Company Profile
ID · 15959e74-94b8-4318-98c8-cd3427fd4029
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 928372
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
6- 21 CFR 211.84(a)Components withheld from use pending release
- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.194(a)(2)Test methods ID and data location
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.80(a)Written Procedures Not Followed
- 21 CFR 211.100(b)SOPs not followed / documented
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