Drug factory · FDA FEI 1811396
Catalent Pharma Solutions, LLC
2725 Scherer Drive North, St Petersburg, FL, United States
Problems found, fixed voluntarily at FDA's last inspection, Jan 30, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
9 drug inspections on record since 2009: 1 with no problems, 8 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Bexarotene | Makes it | Bausch Health US, LLC | 0187-5526 |
| Dutasteride | Makes it and tests it | Waylis Therapeutics LLC | 80725-712 |
| Estradiol | Makes it and tests it | Mayne Pharma Inc. | 68308-747, 68308-748 |
| Estradiol and Progesterone | Makes it and tests it | Mayne Pharma Inc., Mayne Pharma LLC | 68308-750, 68308-751, 50261-211 +1 |
| Lubiprostone | Makes it and tests it | Caraco Pharmaceutical Laboratories, Ltd. | 63304-351, 63304-352 |
| Omega-3 Fatty Acids | Makes it and tests it | Waylis Therapeutics LLC | 80725-420 |
| Progesterone | Makes it | Acertis Pharmaceuticals, LLC | 72989-372, 72989-373 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 30, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 30, 2024 | No problems found | Drug Quality Assurance | — |
| Feb 22, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jun 14, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Mar 25, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 25, 2016 | Problems found, fixed voluntarily | Bioresearch Monitoring | — |
| Dec 30, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 29, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 6, 2009 | 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 22, 2019 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. - 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. - Written program not followed 21 CFR 211.166(a)
The written stability testing program is not followed.
Jun 14, 2018 inspection
- Written in-process control procedures 21 CFR 211.110(a)
Written procedures are not followed that describe the examinations to be conducted on appropriate samples of in-process materials of each batch. - 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 and followed. - Quality control unit review of records 21 CFR 211.192
Drug product production and control records, are not reviewed by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. - 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.
Registered with FDA for: analysis; label; manufacture; pack.