Drug factory · FDA FEI 3002784388
Rainbow Gold Products, Inc.
1610 Sardis Drive, Sardis City, AL, United States
Problems found, fixed voluntarily at FDA's last inspection, Jun 18, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2009: 1 with no problems, 3 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Diclofenac and Menthol | Repackages it | Primary Pharmaceuticals, Inc. | 72275-719 |
| Dimethicone and Triamcinolone Acetonide | Repackages it | Primary Pharmaceuticals, Inc. | 72275-709 |
| Lidocaine | Repackages it | Primary Pharmaceuticals, Inc. | 72275-716 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 18, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Aug 11, 2016 | Serious problems, FDA action | Unapproved and Misbranded Drugs | — |
| Aug 11, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 5, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 21, 2009 | 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.
Jun 18, 2026 inspection
- Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Registered with FDA for: relabel; repack.