Form FDA 483 · Issued 2026-05-08
Philips Oral Healthcare, LLC — FDA Form 483 Analysis
FEI: 1000126901 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Specification Developer) · Lead Investigator: Marcus V. Delgado
FDA Form 483 issued to Philips Oral Healthcare, LLC (FEI 1000126901) on 2026-05-08 following an inspection of its specification developer operations in Washington. The report documents 2 inspection observations centered on Finished Product Testing, Stability & Expiration Dating.
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 211.166(a)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Written program not followed
Inspector Observation Language: "The written stability testing program is not followed. Specifically, observed during inspection of Philips Oral Healthcare, LLC on 2026-05-08."
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 #2 · 21 CFR 211.160(a)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Following/documenting laboratory controls
Inspector Observation Language: "Established [specifications] [standards] [sampling plans] [test procedures] [laboratory control mechanisms] are not [followed] [documented at the time of performance]. Specifically, observed during inspection of Philips Oral Healthcare, LLC on 2026-05-08."
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.