Drug factory · FDA FEI 3002880938
Corden Pharma Spa
Viale dell'Industria 3, Caponago, Italy
Problems found, fixed voluntarily at FDA's last inspection, Mar 28, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
7 drug inspections on record since 2009: 0 with no problems, 7 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Dexmedetomidine | Makes it, tests it, packages it and labels it | Precision Dose Inc. | 68094-047, 68094-147, 68094-247 |
| Diazepam | Makes it | Civica, Inc., Natco Pharma USA LLC | 72572-140, 69339-137 |
| Furosemide | Makes it | Areva Pharmaceuticals, Inc. | 59923-607, 59923-608 |
| Propofol | Makes it, tests it, packages it and labels it | Dr. Reddy's Laboratories Inc., Fresenius Kabi, LLC | 43598-265, 43598-548, 43598-549 +1 |
| Treprostinil | Makes it | Alembic Pharmaceuticals Inc. | 62332-514, 62332-515, 62332-516 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 28, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 2, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 14, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 15, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 14, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 28, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | 7 |
| Jul 16, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Oct 28, 2011 inspection
- Control procedures to monitor and validate performance 21 CFR 211.110(a)
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product. - 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. - Prepared for each batch, include complete information 21 CFR 211.188
Batch production and control records do not include complete information relating to the production and control of each batch. - Training--operations, GMPs, written procedures 21 CFR 211.25(a)
Employees are not given training in the particular operations they perform as part of their function. - Protective Apparel Not Worn 21 CFR 211.28(a)
Protective apparel is not worn as necessary to protect drug products from contamination. - Written procedures lacking for use of pesticides etc. 21 CFR 211.56(c)
Written procedures are lacking for the use of cleaning and sanitizing agents designed to prevent the contamination of equipment, components, drug product containers, closures, and drug products. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Jul 16, 2009 inspection
- Microbiological testing 21 CFR 211.165(b)
Each batch of drug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.
Registered with FDA for: analysis; label; manufacture; pack.