Form FDA 483 · Issued 2026-02-12
Waylis Therapeutics LLC — FDA Form 483 Analysis
FEI: 3021614574 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Corporate Office) · Lead Investigator: Thomas W. Halvorsen
FDA Form 483 issued to Waylis Therapeutics LLC (FEI 3021614574) on 2026-02-12 following an inspection of its corporate office operations in New Jersey. The report documents 3 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention, Finished Product Testing, Stability & Expiration Dating.
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Observation-by-Observation 21 CFR Breakdown (3)
Observation #1 · 21 CFR 314.80(d)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Failure to submit scientific article
Inspector Observation Language: "A postmarketing 15-day Alert report based upon scientific literature was not accompanied by a copy of the published article. Specifically, observed during inspection of Waylis Therapeutics LLC on 2026-02-12."
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.
Observation #2 · 21 CFR 212.60(c)
Finished Product Testing, Stability & Expiration Dating
REPEAT CITATION AT FACILITY
Analytical methods
Inspector Observation Language: "Your laboratory analytical methods are not [suitable for their intended use] [sufficiently sensitive] [sufficiently specific] [sufficiently accurate] [sufficiently reproducible]. Specifically, observed during inspection of Waylis Therapeutics LLC on 2026-02-12."
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 212.110(b)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Record quality
Inspector Observation Language: "All records including those not stored at your inspected establishment are not [legible] [stored to prevent deterioration or loss] [readily available for review and copying by FDA employees]. Specifically,observed during inspection of Waylis Therapeutics LLC on 2026-02-12."
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.