Drug factory · FDA FEI 3007209985
Corerx, Inc.
14205 Myerlake Circle, Clearwater, FL, United States
Problems found, fixed voluntarily at FDA's last inspection, Feb 26, 2026.
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 2015: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Aminocaproic Acid | Makes it | BPI Labs, LLC, airis PHARMA Private Limited | 54288-151, 71151-026 |
| Amphetamine | Makes it | Bionpharma Inc. | 69452-227, 69452-228 |
| Atovaquone | Makes it | Bionpharma Inc. | 69452-252 |
| Clobazam | Makes it | Bionpharma Inc. | 69452-116 |
| Eflornithine | Makes it and tests it | Uswm, LLC | 78670-150 |
| Enalaprilat | Makes it | Bionpharma Inc. | 69452-237 |
| Finasteride and Tadalafil | Makes it | Veru Inc. | 69681-125 |
| Mycophenolic Acid | Makes it, tests it, packages it and labels it | Rising Pharma Holdings, Inc. | 16571-282 |
| Rufinamide | Makes it | Bionpharma Inc. | 69452-223 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 26, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 14 |
| Feb 26, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 14 |
| Aug 13, 2021 | No problems found | Drug Quality Assurance | — |
| Aug 13, 2021 | No problems found | Drug Quality Assurance | — |
| Mar 6, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 6, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 27, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 27, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 19, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 19, 2015 | 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.
Feb 26, 2026 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess. - Absence of Written Procedures 21 CFR 211.100(a)
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess. - 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 established, written and followed. - 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 established, written and followed. - Washing and toilet facilities are deficient 21 CFR 211.52
Washing and toilet facilities lack hot and cold water, soap or detergent, air driers or single-service towels and cleanliness. - Washing and toilet facilities are deficient 21 CFR 211.52
Washing and toilet facilities lack hot and cold water, soap or detergent, air driers or single-service towels and cleanliness. - Buildings not maintained in good state of repair 21 CFR 211.58
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair. - Buildings not maintained in good state of repair 21 CFR 211.58
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair. - 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. - 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. - Representative Samples Criteria 21 CFR 211.84(b)
The number of containers to be sampled and amount of material taken from each container is not based upon appropriate criteria. - Representative Samples Criteria 21 CFR 211.84(b)
The number of containers to be sampled and amount of material taken from each container is not based upon appropriate criteria. - Component written specification 21 CFR 211.84(d)(2)
Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality. - Component written specification 21 CFR 211.84(d)(2)
Component testing is deficient in that each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.
Registered with FDA for: analysis; label; manufacture; pack.