Drug factory · FDA FEI 1150049
Arcet Equipment Company dba Arc3 Gases North
3416 Odd Fellows Rd, Lynchburg, VA, United States
Problems found, fixed voluntarily at FDA's last inspection, Jun 8, 2010.
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 2010: 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 | 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 |
|---|---|---|---|
| Jun 8, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jun 8, 2010 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. - Testing and release for distribution 21 CFR 211.165(a)
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release. - 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. - GMP Training Frequency 21 CFR 211.25(a)
GMP training is not conducted on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
Registered with FDA for: manufacture.