Form FDA 483 · Issued 2026-03-18
Cardinal Health 414, LLC — FDA Form 483 Analysis
FEI: 3004750502 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Pet Drug Manufacturer) · Lead Investigator: David K. Chen
FDA Form 483 issued to Cardinal Health 414, LLC (FEI 3004750502) on 2026-03-18 following an inspection of its pet drug manufacturer operations in Mississippi. The report documents 4 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Electronic Record Data Integrity (21 CFR Part 11) & Retention.
Get Full Annotated 483 Dossier + CAPA Checklist
Instant PDF + CFR Matrix ($79 vs. Redica's $289)
Need Help Fixing These 4 Citations?
Get matched with a vetted 21 CFR remediation consultant
Observation-by-Observation 21 CFR Breakdown (4)
Observation #1 · 21 CFR 211.84(a)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Components withheld from use pending release
Inspector Observation Language: "Each lot of [components] [drug product containers] [closures] is not withheld from use until the lot has been sampled, tested, examined, and released by the quality control unit. Specifically, observed during inspection of Cardinal Health 414, LLC on 2026-03-18."
Plain-English Meaning: Failure to perform at least one test to verify the identity of every incoming dietary ingredient or raw component before use, or relying on a supplier's Certificate of Analysis (COA) without first qualifying the supplier.
Standard CAPA Remediation Path: Establish SOP-QA-004 requiring FTIR/HPLC/organoleptic identity testing on 100% of incoming dietary ingredient lots and annual audit + 3-lot confirmatory testing before relying on any vendor COA.
Observation #2 · FDCA 501(a)(2)(A)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Media fills, failure
Inspector Observation Language: "Failure to conduct media fills that closely simulate aseptic production operations under the worst-case, most-challenging, and stressful conditions. Specifically, observed during inspection of Cardinal Health 414, LLC on 2026-03-18."
Plain-English Meaning: Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
Standard CAPA Remediation Path: Enforce unique user credentials, immutable audit trails on analytical instruments, controlled form issuance numbers, and 2-year post-expiration record retention.
Observation #3 · 21 CFR 211.80(b)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Handling and Storage to Prevent Contamination
Inspector Observation Language: "There was a failure to handle and store [components] [drug product containers] [closures] at all times in a manner to prevent contamination. Specifically, observed during inspection of Cardinal Health 414, LLC on 2026-03-18."
Plain-English Meaning: Failure to perform at least one test to verify the identity of every incoming dietary ingredient or raw component before use, or relying on a supplier's Certificate of Analysis (COA) without first qualifying the supplier.
Standard CAPA Remediation Path: Establish SOP-QA-004 requiring FTIR/HPLC/organoleptic identity testing on 100% of incoming dietary ingredient lots and annual audit + 3-lot confirmatory testing before relying on any vendor COA.
Observation #4 · 21 CFR 314.80(c)(1)(i)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
REPEAT CITATION AT FACILITY
Late submission of 15-day report
Inspector Observation Language: "Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information. Specifically, observed during inspection of Cardinal Health 414, LLC on 2026-03-18."
Plain-English Meaning: Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
Standard CAPA Remediation Path: Enforce unique user credentials, immutable audit trails on analytical instruments, controlled form issuance numbers, and 2-year post-expiration record retention.