Drug factory · FDA FEI 3003391863
Robinson`s Industrial Gas & Equipment Corp.
920 LINCOLN AVE UNIT 14, Holbrook, NY, United States
No problems found at FDA's last inspection, Jul 11, 2013.
No Action Indicated: inspectors found no objectionable conditions.
3 drug inspections on record since 2009: 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 | Robinson`s Industrial Gas & Equipment Corp. | 66487-002 |
| Oxygen | Makes it | Robinson`s Industrial Gas & Equipment Corp. | 66487-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 11, 2013 | No problems found | Drug Quality Assurance | — |
| Jun 8, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Aug 13, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
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, 2012 inspection
- 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.
Aug 13, 2009 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. - Description of containers and closures 21 CFR 211.188(b)(9)
Batch production and control records do not include a description of drug product containers used for each batch of drug product produced.
Registered with FDA for: manufacture.