Drug factory · FDA FEI 1937815
R.D. Laboratories, Inc.
204 Lange Drive, Washington, MO, United States
Problems found, fixed voluntarily at FDA's last inspection, Jan 26, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2010: 4 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Abametapir | Tests it | Dr. Reddy's Laboratories Inc. | 43598-921 |
| Oxcarbazepine | Tests it | Ajanta Pharma USA Inc. | 27241-304, 27241-305, 27241-306 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 26, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 27, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Nov 2, 2016 | No problems found | Drug Quality Assurance | — |
| Apr 8, 2014 | No problems found | Drug Quality Assurance | — |
| Oct 5, 2011 | No problems found | Drug Quality Assurance | — |
| Jan 6, 2010 | No problems found | 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.
Aug 27, 2021 inspection
- Authority lacking to review records, investigate errors 21 CFR 211.22(a)
The quality control unit lacks authority to fully investigate errors that have occurred. - 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. - Buildings not maintained in good state of repair 21 CFR 211.58
Buildings used in the processing of a drug product are not maintained in a good state of repair. - Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Registered with FDA for: analysis.