Drug factory · FDA FEI 3004262443
Arcet Equipment Company dba Arc3 Gases North
304 E 25th S, Norfolk, VA, United States
No problems found at FDA's last inspection, May 22, 2012.
No Action Indicated: inspectors found no objectionable conditions.
3 drug inspections on record since 2011: 1 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Nitrogen | Makes it | Arcet Equipment Company dba Arc3 Gases North | 59788-002 |
| Oxygen | Makes it | Arcet Equipment Company dba Arc3 Gases North | 59788-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 22, 2012 | No problems found | Drug Quality Assurance | — |
| Jul 21, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Jul 21, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jul 21, 2011 inspection
- Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. - GMP Training Frequency 21 CFR 211.25(a)
GMP training is not conducted on a continuing basis to assure that employees remain familiar with CGMP requirements applicable to them.
Registered with FDA for: manufacture.