Drug factory · FDA FEI 3002806546
Catalent Anagni S.R.L.
STRADA PROVINCIALE 12 CASILINA 41, Anagni (fontana Del Ceraso), Italy
Problems found, fixed voluntarily at FDA's last inspection, Feb 23, 2024.
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 2011: 0 with no problems, 7 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Cx-055611 | Makes it, tests it, packages it and labels it | Moderna US, Inc. | 80777-114, 80777-115 |
| Nirsevimab | Makes it and tests it | Sanofi Vaccines US Inc. | 49281-574, 49281-575 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 23, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 14, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 31, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 20, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 6 |
| Jul 2, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Mar 8, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 15, 2011 | 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.
Nov 20, 2015 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. - Procedure Deviations Recorded and Justified 21 CFR 211.100(b)
Deviations from written production and process control procedures are not recorded. - SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not documented at the time of performance. - Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. - Equipment for Environmental Control 21 CFR 211.46(b)
Equipment for adequate control over humidity is not provided when appropriate for the manufacture, processing, packing or holding of a drug product. - Buildings not maintained in good state of repair 21 CFR 211.58
Buildings used in the processing and holding of a drug product are not maintained in a good state of repair.
Jul 2, 2013 inspection
- Cleaning System 21 CFR 211.42(c)(10)(v)
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
Registered with FDA for: analysis; label; manufacture; pack.