IntegraDose Compounding Services LLC
Registered Address: Minnesota, United States (United States)
5 Questions to Ask IntegraDose Compounding Services LLC Before Signing a Manufacturing Contract
Bring these exact questions to your discovery call with their QA Director or account rep before wiring a production deposit:
- Q1: On 2026-08-12, FDA cited 21 CFR 211.68(a) (Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
- Q2: On 2026-08-12, FDA cited 21 CFR 211.166(a) (Finished Product Testing, Stability & Expiration Dating). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
- Q3: On 2026-08-12, FDA cited 21 CFR 211.84(d)(1) (Incoming Ingredient Identity Testing & COA Qualification). Can your Quality Unit share the signed 15-day CAPA response and verification logs showing this gap is closed?
- Q4: Do you perform 100% FTIR/HPLC identity testing on incoming active ingredients in-house (21 CFR 111.75(a)(1)), or do you rely on vendor COAs?
- Q5: Will you sign our Quality Agreement Rider requiring 24-hour notification if an FDA investigator issues a Form 482 or Form 483 at FEI 3014483112?
Cross-Database Regulatory & Inspection Timeline
Unified chronological history across FDA ORA Inspections, Form 483s, Warning Letters, Enforcement Recalls, and OASIS Import Refusals.
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.
- 21 CFR 211.68(a) (Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems): Scales, thermometers, pH meters, autoclaves, or purified water systems lacking current NIST-traceable calibration or process validation. REPEAT OBSERVATION
- 21 CFR 211.166(a) (Finished Product Testing, Stability & Expiration Dating): 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.
- 21 CFR 211.84(d)(1) (Incoming Ingredient Identity Testing & COA Qualification): 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.
- 21 CFR 211.22(a) (Electronic Record Data Integrity (21 CFR Part 11) & Retention): Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
FDA Demand: Provide a comprehensive independent assessment of your quality unit, complete batch record remediation plan, and retrospective stability/identity testing data within 15 working days.
Manufacturer Right-of-Reply & Free Match Correction
GUARDRAIL PROTECTEDTo ensure fairness and accuracy, facility owners may submit verified Form 483 closeout evidence, CAPA completion statements, or entity-resolution corrections free of charge. Sponsorship never alters an FDA Record Index score.
6-Subsystem cGMP Radar Breakdown
Sub-scores mapped across FDA's six core inspection subsystems.
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Score Provenance Receipts
Every point in this facility's FDA Record Index (40/100) is backed by a linked government record (36-month half-life decay).
| Event | Date | Weight | Receipt |
|---|---|---|---|
| Inspection Outcome (VAI) | 2026-08-12 | -9.5 pts | INSP-483-3014483112-20260812 ↗ |
| Form 483 (4 observations, 1 repeat) | 2026-08-12 | -14.2 pts | 483-3014483112-20260812 ↗ |
| Warning Letter (Open) | 2026-07-15 | -28.0 pts | CMS-684110 ↗ |