Drug factory · FDA FEI 3001451366
Patheon Softgels Inc.
4125 Premier Dr, High Point, NC, United States
Problems found, fixed voluntarily at FDA's last inspection, Jul 17, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
10 drug inspections on record since 2009: 7 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Amantadine | Makes it and tests it | Bionpharma Inc., Bryant Ranch Prepack | 69452-142, 63629-2681 |
| Benzonatate | Makes it | Bionpharma Inc. | 69452-143, 69452-144 |
| Calcitriol | Makes it | Bionpharma Inc. | 69452-207, 69452-208 |
| Diclofenac | Makes it | Teva Pharmaceuticals, Inc. | 0480-9435 |
| Dronabinol | Makes it | Ascend Laboratories, LLC, The Pharma Network LLC | 67877-753, 67877-754, 67877-755 +3 |
| Ergocalciferol | Makes it | Bionpharma Inc. | 69452-151 |
| Ethinyl Estradiol and Norethindrone | Makes it and tests it | Xiromed, LLC. | 70700-152 |
| Ethosuximide | Makes it | Bionpharma Inc. | 69452-152 |
| Monomethyl | Makes it | Banner Life Sciences LLC. | 69387-001 |
| Nimodipine | Makes it | Bionpharma Inc. | 69452-209 |
| Omega-3 Fatty Acids | Makes it | Bionpharma Inc. | 69452-175 |
| Paricalcitol | Makes it and tests it | Bionpharma Inc. | 69452-145, 69452-146, 69452-147 |
| Progesterone | Makes it and tests it | Bionpharma Inc. | 69452-148, 69452-149, 69452-233 +1 |
| Valproic Acid | Makes it | Bionpharma Inc. | 69452-150 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 17, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jan 30, 2019 | No problems found | Drug Quality Assurance | — |
| Aug 11, 2017 | No problems found | Drug Quality Assurance | — |
| Jan 29, 2015 | No problems found | Drug Quality Assurance | — |
| Sep 18, 2013 | No problems found | Drug Quality Assurance | — |
| Sep 26, 2012 | No problems found | Bioresearch Monitoring | — |
| Jul 2, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 6, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Sep 14, 2010 | No problems found | Bioresearch Monitoring | — |
| Sep 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.
Jul 17, 2025 inspection
- Batch production and Batch Control Record Requirements 21 CFR 211.188(b)
The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing. - 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. - Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Jun 6, 2012 inspection
- Manufacturing operations - written procedures 21 CFR 111.353
You did not follow written procedures for manufacturing operations. - Manufacturing operations - prevent contamination 21 CFR 111.365
You did not take necessary precautions during the manufacture of a dietary supplement to prevent contamination of dietary supplements.
Registered with FDA for: analysis; manufacture; pack.