Drug factory · FDA FEI 3004813394
Sunrise Pharmaceutical Inc
665 East Lincoln Avenue, Rahway, NJ, United States
Problems found, fixed voluntarily at FDA's last inspection, Mar 31, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
8 drug inspections on record since 2009: 3 with no problems, 4 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Acetaminophen and Butalbital and Caffeine | Makes it, packages it and labels it | Sunrise Pharmaceutical, Inc. | 11534-187 |
| Amphetamine and Dextroamphetamine | Makes it, tests it and labels it | Sunrise Pharmaceutical, Inc. | 11534-190, 11534-191, 11534-192 +4 |
| Chlordiazepoxide and Clidinium | Makes it, tests it, packages it and labels it | Sunrise Pharmaceutical, Inc. | 11534-197 |
| Dextroamphetamine | Makes it | Sunrise Pharmaceutical, Inc. | 11534-188, 11534-189 |
| Folic Acid | Makes it | Sunrise Pharmaceutical, Inc. | 11534-165 |
| Methscopolamine | Makes it | Unichem Pharmaceuticals (USA), Inc. | 76385-100, 76385-101 |
| Phentermine | Makes it, packages it and labels it | Calvin Scott & Co., Inc., Medsource Pharmaceuticals, Sunrise Pharmaceutical, Inc. | 17224-851, 17224-904, 45865-222 +4 |
| Polystyrene Sulfonic Acid | Makes it, tests it, packages it and labels it | Sunrise Pharmaceutical, Inc. | 11534-166 |
| Sulfasalazine | Tests it, packages it and labels it | Sunrise Pharmaceutical, Inc. | 11534-201 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 31, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jan 27, 2023 | No problems found | Drug Quality Assurance | — |
| Jan 18, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Apr 6, 2017 | No problems found | Drug Quality Assurance | — |
| Jan 8, 2014 | No problems found | Drug Quality Assurance | — |
| Oct 4, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Dec 20, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Jul 17, 2009 | Serious problems, FDA action | Drug Quality Assurance | 11 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Mar 31, 2026 inspection
- Storage under appropriate conditions 21 CFR 211.142(b)
Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality, and purity are not affected.
Jan 18, 2018 inspection
- 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.
Oct 4, 2011 inspection
- Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed.
Dec 20, 2010 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. - Complete instructions, procedures, specifications et. al. 21 CFR 211.186(b)(9)
Master production and control records lack complete manufacturing and control instructions.
Registered with FDA for: analysis; label; manufacture; pack.