Form FDA 483 · Issued 2026-08-12
IntegraDose Compounding Services LLC — FDA Form 483 Analysis
FEI: 3014483112 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Outsourcing Facility) · Lead Investigator: David K. Chen
FDA Form 483 issued to IntegraDose Compounding Services LLC (FEI 3014483112) on 2026-08-12 following an inspection of its outsourcing facility operations in Minnesota. The report documents 4 inspection observations centered on Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems, Finished Product Testing, Stability & Expiration Dating.
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Observation-by-Observation 21 CFR Breakdown (4)
Observation #1 · 21 CFR 211.68(a)
Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems
REPEAT CITATION AT FACILITY
Calibration/Inspection/Checking not done
Inspector Observation Language: "Routine [calibration] [inspection] [checking] of [automatic] [mechanical] [electronic] equipment is not performed according to a written program designed to assure proper performance. Specifically, observed during inspection of IntegraDose Compounding Services LLC on 2026-08-12."
Plain-English Meaning: Scales, thermometers, pH meters, autoclaves, or purified water systems lacking current NIST-traceable calibration or process validation.
Standard CAPA Remediation Path: Tag all critical measuring instruments with calibration due dates, lock out overdue devices, and perform weekly TOC/conductivity/bioburden testing on purified water loops.
Observation #2 · 21 CFR 211.166(a)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Lack of written stability program
Inspector Observation Language: "There is no written testing program designed to assess the stability characteristics of drug products. Specifically, observed during inspection of IntegraDose Compounding Services LLC on 2026-08-12."
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 #3 · 21 CFR 211.84(d)(1)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Identity Testing of Each Component
Inspector Observation Language: "The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist. Specifically, observed during inspection of IntegraDose Compounding Services LLC on 2026-08-12."
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 211.22(a)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Lack of quality control unit
Inspector Observation Language: "There is no quality control unit. Specifically, observed during inspection of IntegraDose Compounding Services LLC on 2026-08-12."
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.