Drug factory · FDA FEI 3009993897
Neolpharma, Inc.
99 Jardines Street, Caguas, PR, United States
Problems found, fixed voluntarily at FDA's last inspection, Mar 10, 2026.
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 2013: 0 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Amphetamine and Amphetamine Aspartate and Dextroamphetamine | Makes it, tests it, packages it and labels it | Glenmark Pharmaceuticals Inc., USA | 68462-647, 68462-649, 68462-651 +2 |
| Atorvastatin | Makes it | Biocon Pharma Inc. | 70377-077, 70377-078, 70377-079 +1 |
| Atropine and Diphenoxylate | Makes it, tests it, packages it and labels it | Neolpharma, Inc. | 55466-783 |
| Levothyroxine | Makes it, tests it, packages it and labels it | Lannett Company, Inc. | 0527-3280, 0527-3281, 0527-3282 +9 |
| Linezolid | Makes it, packages it and labels it | Pharmacia & Upjohn Company LLC | 0009-5136, 0009-5138 |
| Meloxicam | Makes it | Iroko Pharmaceuticals, LLC | 42211-205, 42211-206 |
| Oseltamivir Acid | Makes it, tests it, packages it and labels it | Exelan Pharmaceuticals, Inc. | 76282-702, 76282-703, 76282-704 |
| Theophylline | Makes it, tests it, packages it and labels it | ENDO USA, Inc. | 52244-100, 52244-200, 52244-300 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 10, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Apr 1, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Feb 5, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jun 7, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 18, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 7, 2013 | Problems found, fixed voluntarily | 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.
Mar 10, 2026 inspection
- 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. - Sanitation--buildings not clean, free of infestation 21 CFR 211.56(a)
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition and free of infestation by rodents, birds insects, and other vermin.
Apr 1, 2022 inspection
- SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance.
Feb 5, 2019 inspection
- Procedures for non-sterile drug products 21 CFR 211.113(a)
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not followed.
Registered with FDA for: analysis; label; manufacture; pack.