Form FDA 483 · Issued 2026-03-20
BioLife Plasma Services L.P. — FDA Form 483 Analysis
FEI: 3023831018 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Source Plasma Establishment) · Lead Investigator: Priya N. Subramanian
FDA Form 483 issued to BioLife Plasma Services L.P. (FEI 3023831018) on 2026-03-20 following an inspection of its source plasma establishment operations in California. The report documents 2 inspection observations centered on Finished Product Testing, Stability & Expiration Dating, Cleaning Validation, Sanitation Logs & Pest Control.
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Observation-by-Observation 21 CFR Breakdown (2)
Observation #1 · 21 CFR 211.160(b)(4)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Calibration - at intervals, written program, remedial action
Inspector Observation Language: "The calibration of [instruments] [apparatus] [gauges] [recording devices] is not done at suitable intervals [in accordance with an established written program] [with provisions for remedial action in the event accuracy and/or precision limits are not met]. Specifically, observed during inspection of BioLife Plasma Services L.P. on 2026-03-20."
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 211.67(c)
Cleaning Validation, Sanitation Logs & Pest Control
FIRST-TIME OBSERVATION
Cleaning/maintenance records not kept
Inspector Observation Language: "Records are not kept for the [maintenance] [cleaning] [sanitizing] [inspection] of equipment. Specifically, observed during inspection of BioLife Plasma Services L.P. on 2026-03-20."
Plain-English Meaning: Incomplete equipment cleaning/sanitation logs, inadequate allergen or cross-contamination changeover validation, or gaps in facility pest exclusion.
Standard CAPA Remediation Path: Implement lot-linked equipment cleaning verification logs with QA sign-off before line clearance, ATP/allergen swabbing after shared-line runs, and weekly documented pest-control inspections.