Drug factory · FDA FEI 3014926340
RK Pharma Inc.
401 N MIDDLETOWN RD BLG 215/215 A, Pearl River, NY, United States
Problems found, fixed voluntarily at FDA's last inspection, May 31, 2024.
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 2024: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Isopropyl Alcohol and Leuprolide | Makes it, tests it and packages it | VGYAAN Pharmaceuticals LLC | 72664-611 |
| Mitomycin | Makes it | Archis Pharma LLC | 72819-152 |
| Mycophenolic Acid | Makes it | Archis Pharma LLC | 72819-155, 72819-156 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 31, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 5 |
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 31, 2024 inspection
- Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. - Records of disposition of rejected material 21 CFR 211.184(e)
Records do not include the disposition of rejected drug product containers. - Equipment Design, Size and Location 21 CFR 211.63
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product. - 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; manufacture; pack.