Drug factory · FDA FEI 3003057063
Machine & Welding Supply Company dba Arc3 Gases South
519 Hwy 124, Greenville, SC, United States
Problems found, fixed voluntarily at FDA's last inspection, Aug 12, 2016.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2016: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Nitrogen | Makes it | Machine & Welding Supply Company dba Arc3 Gases South | 49575-002 |
| Oxygen | Makes it | Machine & Welding Supply Company dba Arc3 Gases South | 49575-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 12, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 9 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Aug 12, 2016 inspection
- Strict control not exercised over labeling issued 21 CFR 211.125(a)
Strict control is not exercised over labeling issued for use in drug product labeling operations. - Examination of issued labels 21 CFR 211.125(b)
Labeling materials issued for a batch were not carefully examined for identity and conformity to the labeling specified in the master or batch production records. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed. - Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the education and training required to perform their assigned functions. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine calibration of mechanical equipment is not performed according to a written program designed to assure proper performance. - Component written specification 21 CFR 211.84(d)(2)
Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality. - Establish reliability of supplier's C of A 21 CFR 211.84(d)(2)
Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals. - Testing Each Component for Conformity with Specs 21 CFR 211.84(d)(2)
Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
Registered with FDA for: manufacture.