Drug factory · FDA FEI 2434153
Amneal Pharmaceuticals of New York, LLC
75 Adams Ave, Hauppauge, NY, United States
No problems found at FDA's last inspection, Feb 3, 2020.
No Action Indicated: inspectors found no objectionable conditions.
12 drug inspections on record since 2009: 4 with no problems, 8 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Acetaminophen and Codeine | Makes it | RxChange Co. | 33358-001 |
| Amlodipine | Makes it | New Horizon Rx Group, LLC | 58517-120 |
| Ibuprofen | Makes it | RxChange Co. | 33358-188 |
| Metformin | Makes it, tests it, packages it and labels it | Amneal Pharmaceuticals | 65162-175 |
| Naproxen | Makes it | New Horizon Rx Group, LLC | 58517-300 |
| Phenazopyridine | Makes it, tests it, packages it and labels it | Amneal Pharmaceuticals | 60846-501, 60846-502 |
| Phenytoin | Makes it, tests it, packages it and labels it | Amneal Pharmaceuticals | 65162-212 |
| Salsalate | Makes it, tests it, packages it and labels it | Amneal Pharmaceuticals | 65162-512, 65162-513 |
| Sulfamethoxazole and Trimethoprim | Makes it | New Horizon Rx Group, LLC | 58517-140 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 3, 2020 | No problems found | Drug Quality Assurance | — |
| Mar 18, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Apr 11, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Aug 9, 2016 | Problems found, fixed voluntarily | Bioresearch Monitoring | 3 |
| Mar 16, 2015 | No problems found | Drug Quality Assurance | — |
| Feb 7, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 7, 2014 | Problems found, fixed voluntarily | Bioresearch Monitoring | — |
| May 15, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Oct 29, 2010 | No problems found | Drug Quality Assurance | — |
| May 26, 2010 | No problems found | Bioresearch Monitoring | — |
| Nov 24, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 18, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
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 18, 2019 inspection
- Storage under appropriate conditions 21 CFR 211.142(b)
Drug products are not stored under appropriate conditions of humidity so that their identity, strength, quality, and purity are not affected.
Apr 11, 2017 inspection
- Clothing appropriate for duties performed 21 CFR 211.28(a)
Clothing of personnel engaged in the processing and packing of drug products is not appropriate for the duties they perform.
Aug 9, 2016 inspection
- Late submission of annual safety reports 21 CFR 314.80(c)(2)
Not all annual periodic adverse drug experience reports have been submitted within 60 days of the anniversary date of the approval of the application. - Late submission of quarterly safety reports 21 CFR 314.80(c)(2)
Not all quarterly periodic adverse drug experience reports have been submitted within 30 days of the close of the quarter. - Timely submission 21 CFR 314.81(b)(2)
An annual report was not submitted each year and within 60 days of the anniversary date of U.S. approval of the application to the FDA division responsible for reviewing the application.
May 15, 2012 inspection
- Complaint Handling Procedure 21 CFR 211.198(a)
Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.
Registered with FDA for: analysis; label; manufacture; pack.