Form FDA 483 · Issued 2026-03-26
Becton Dickinson Infusion Therapy Systems, Inc. — FDA Form 483 Analysis
FEI: 1710034 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Drug Manufacturer) · Lead Investigator: David K. Chen
FDA Form 483 issued to Becton Dickinson Infusion Therapy Systems, Inc. (FEI 1710034) on 2026-03-26 following an inspection of its drug manufacturer operations in Utah. The report documents 4 inspection observations centered on Finished Product Testing, Stability & Expiration Dating, Incoming Ingredient Identity Testing & COA Qualification.
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Observation-by-Observation 21 CFR Breakdown (4)
Observation #1 · 21 CFR 211.194(a)(4)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Complete Test Data
Inspector Observation Language: "Laboratory records are deficient in that they do not include a complete record of all data obtained during testing. Specifically, observed during inspection of Becton Dickinson Infusion Therapy Systems, Inc. on 2026-03-26."
Plain-English Meaning: Releasing finished batches without verifying strength/potency/microbiological specs, or placing an expiration/best-by date on labels without supporting real-time or accelerated stability data.
Standard CAPA Remediation Path: Require finished-batch microbiological (USP <2021>/<2022>), heavy metal, and active-assay release testing plus ICH stability chamber protocols supporting every label shelf-life claim.
Observation #2 · 21 CFR 212.50
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Adequate controls (general)
Inspector Observation Language: "Your firm lacks adequate production and process controls to ensure the consistent production of a PET drug that meets the applicable standards of identity, strength, quality and purity. Specifically,observed during inspection of Becton Dickinson Infusion Therapy Systems, Inc. on 2026-03-26."
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 #3 · 21 CFR 211.192
Incoming Ingredient Identity Testing & COA Qualification
REPEAT CITATION AT FACILITY
Extent of discrepancy, failure investigations
Inspector Observation Language: "Investigations of [an unexplained discrepancy] [a failure of a batch or any of its components to meet any of its specifications] did not extend to [other batches of the same drug product] [other drug products that may have been associated with the specific failure or discrepancy]. Specifically, observed during inspection of Becton Dickinson Infusion Therapy Systems, Inc. on 2026-03-26."
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 212.30(a)
Personnel GMP Training, Gowning & Hygienic Practices
FIRST-TIME OBSERVATION
Orderly handling, prevention of mix-ups, prevention of contamination
Inspector Observation Language: "Your facilities are not adequate to ensure [the orderly handling of materials and equipment] [the prevention of mix-ups] [the prevention of contamination of equipment or product by substances, personnel, or environmental conditions] that could reasonably be expected to have an adverse effect on product quality. Specifically, observed during inspection of Becton Dickinson Infusion Therapy Systems, Inc. on 2026-03-26."
Plain-English Meaning: Operators performing manufacturing or QA tasks without documented GMP/SOP training, or observed gowning/hygiene deviations in production rooms.
Standard CAPA Remediation Path: Maintain role-based SOP training matrices signed prior to independent floor assignment and annual cGMP refresher assessments.