Form FDA 483 · Issued 2026-02-09
Collaborative Care Diagnostics, LLC — FDA Form 483 Analysis
FEI: 3002619777 · Sector: Medical Devices (Manufacturer) · Lead Investigator: Priya N. Subramanian
FDA Form 483 issued to Collaborative Care Diagnostics, LLC (FEI 3002619777) on 2026-02-09 following an inspection of its manufacturer operations in Minnesota. The report documents 2 inspection observations centered on Master Manufacturing & Batch Production Records (MMR/BPR), Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems.
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 820.30(g)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Design validation - production units
Inspector Observation Language: "The design was not validated [under defined operating conditions] [using initial production units, lots or batches or their equivalents]. Specifically, observed during inspection of Collaborative Care Diagnostics, LLC on 2026-02-09."
Plain-English Meaning: Missing Master Manufacturing Records (MMRs) or incomplete Batch Production Records (BPRs) lacking exact component weights, lot numbers, yield reconciliation, or second-person verification.
Standard CAPA Remediation Path: Ensure every product SKU has an approved MMR matching the exact label claim and every batch record captures raw material lot traceability, in-process weight/pH checks, and QA release signatures.
Observation #2 · 21 CFR 820.72(b)
Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems
FIRST-TIME OBSERVATION
Calibration procedures - content
Inspector Observation Language: "Calibration procedures do not include [specific directions and limits for accuracy and precision] [provisions for remedial action]. Specifically, observed during inspection of Collaborative Care Diagnostics, LLC on 2026-02-09."
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.