Form FDA 483 · Issued 2026-02-13
Snap Diagnostics, LLC. — FDA Form 483 Analysis
FEI: 3000215335 · Sector: Medical Devices (Manufacturer) · Lead Investigator: David K. Chen
FDA Form 483 issued to Snap Diagnostics, LLC. (FEI 3000215335) on 2026-02-13 following an inspection of its manufacturer operations in Illinois. The report documents 4 inspection observations centered on Master Manufacturing & Batch Production Records (MMR/BPR), Electronic Record Data Integrity (21 CFR Part 11) & Retention.
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Observation-by-Observation 21 CFR Breakdown (4)
Observation #1 · 21 CFR 812.140(b)(2)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Sponsor device disposition records inadequate
Inspector Observation Language: "Records of disposition of a device which describe the batch number or code marks of any devices [returned to the sponsor] [repaired] [disposed of by the investigator or another person] and the reasons for and method of disposition reports are not all [accurate] [complete] [current]. Specifically, observed during inspection of Snap Diagnostics, LLC. on 2026-02-13."
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 812.150(a)(1)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Investigator report of unanticipated adverse effects
Inspector Observation Language: "A complete and accurate report of an unanticipated adverse device effect was not prepared and submitted [within 10 working days after first learning of the effect] to [the sponsor] [the reviewing IRB]. Specifically, observed during inspection of Snap Diagnostics, LLC. on 2026-02-13."
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 820.130
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Packaging
Inspector Observation Language: "Device packaging and/or shipping containers are not designed and constructed to protect the device from alteration or damage during processing, storage, handling, and distribution. Specifically, observed during inspection of Snap Diagnostics, LLC. on 2026-02-13."
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 #4 · 21 CFR 820.30(g)
Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems
FIRST-TIME OBSERVATION
Design validation acceptance criteria
Inspector Observation Language: "Acceptance criteria were not established prior to the performance of validation activities. Specifically, observed during inspection of Snap Diagnostics, LLC. on 2026-02-13."
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.