FDA Inspection
Machine & Welding Supply Company dba Arc3 Gases SouthMachine & Welding Supply Company dba Arc3 Gases South – FDA Inspection, Aug 12, 2016
Record Details
This FDA Inspection record concerns Machine & Welding Supply Company dba Arc3 Gases South, with an inspection on August 12, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- August 12, 2016
- Product Type
- Drugs
View Company Profile
ID · 8a079720-2e61-47bd-8d9c-1594edb57eb9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 982821
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
9- 21 CFR 211.84(d)(2)Component written specification
- 21 CFR 211.84(d)(2)Testing Each Component for Conformity with Specs
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.84(d)(2)Establish reliability of supplier"s C of A
- 21 CFR 211.125(b)Examination of issued labels
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.125(a)Strict control not exercised over labeling issued
- 21 CFR 211.22(d)Procedures not in writing, fully followed
Full citation text and observation details available on the Dashboard.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.