FDA Inspection
American Welding & Gas IncAmerican Welding & Gas Inc – FDA Inspection, Sep 24, 2013
Record Details
This FDA Inspection record concerns American Welding & Gas Inc, with an inspection on September 24, 2013, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- American Welding & Gas Inc
- Inspection Date
- September 24, 2013
- Product Type
- Drugs
View Company Profile
ID · b9e07150-f844-40fe-831e-fb183b183ecd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 854020
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.25(a)Training--operations, GMPs, written procedures
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.198(a)Procedures to be written and followed
- 21 CFR 211.165(e)Test methods
- 21 CFR 211.160(b)(4)Calibration - at intervals, written program, remedial action
- 21 CFR 211.150(b)Distribution Recall System
- 21 CFR 211.22(d)Procedures not in writing, fully followed
- 21 CFR 211.180(e)(1)Review of representative number of batches
- 21 CFR 211.182Written records kept in individual logs
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