Drug factory · FDA FEI 1000123110
Richmond Oxygen Company
11009 Richardson Rd, Ashland, VA, United States
Problems found, fixed voluntarily at FDA's last inspection, May 7, 2009.
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 2009: 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 | Richmond Oxygen Company Inc. | 59534-002 |
| Oxygen | Makes it | Richmond Oxygen Company Inc. | 59534-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 7, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | 6 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
May 7, 2009 inspection
- Signature and checking of records -- 2 persons 21 CFR 211.186(a)
The master production and control records for each batch size of drug product are not prepared, dated, and signed by one person with a full handwritten signature. - Prepared for each batch, include complete information 21 CFR 211.188
Batch production and control records do not include complete information relating to the production and control of each batch. - Quality control unit review of records 21 CFR 211.192
Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. - 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 to assure that employees remain familiar with CGMP requirements applicable to them. - Quarantine of Rejected Components et. al. 21 CFR 211.89
Rejected drug product containers are not controlled under a quarantine system designed to prevent their use in manufacturing or processing operations for which they are unsuitable.
Registered with FDA for: manufacture.