Form FDA 483 · Issued 2026-03-04
BioLife Plasma Services L.P. — FDA Form 483 Analysis
FEI: 3024403018 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Source Plasma Donation Center) · Lead Investigator: Thomas W. Halvorsen
FDA Form 483 issued to BioLife Plasma Services L.P. (FEI 3024403018) on 2026-03-04 following an inspection of its source plasma donation center operations in North Carolina. The report documents 3 inspection observations centered on Cleaning Validation, Sanitation Logs & Pest Control, Label Control, Undeclared Allergens & Structure/Function Claims.
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Observation-by-Observation 21 CFR Breakdown (3)
Observation #1 · FDCA 501(a)(2)(A)
Cleaning Validation, Sanitation Logs & Pest Control
FIRST-TIME OBSERVATION
Beta-lactam, hazardous, highly potent drugs, prevention of cross-contamination
Inspector Observation Language: "[Beta-lactam drugs] [Hazardous drugs] [Highly potent drugs] were produced without providing adequate containment, segregation, and/or cleaning of work surfaces, utensils, and/or personnel to prevent cross-contamination. Specifically, observed during inspection of BioLife Plasma Services L.P. on 2026-03-04."
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.
Observation #2 · 21 CFR 211.130
Label Control, Undeclared Allergens & Structure/Function Claims
REPEAT CITATION AT FACILITY
Procedures are written, and followed
Inspector Observation Language: "Procedures designed to assure that correct [labels] [labeling] [packaging materials] are used for drug products are not [written] [followed]. Specifically, observed during inspection of BioLife Plasma Services L.P. on 2026-03-04."
Plain-English Meaning: Undeclared major food allergens (milk, soy, wheat, tree nuts, peanuts, egg, sesame), label mix-ups at the packaging line, or unauthorized disease treatment claims.
Standard CAPA Remediation Path: Implement 100% barcode/vision verification on packaging lines, strict allergen matrix segregation, and regulatory review removing disease endpoints from supplement/cosmetic copy.
Observation #3 · 21 CFR 211.84(e)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Rejecting When Specifications Not Met
Inspector Observation Language: "Failure to reject any lot of [components] [drug product containers] [closures] that did not meet the appropriate written specifications for identity, strength, quality, and purity. Specifically, observed during inspection of BioLife Plasma Services L.P. on 2026-03-04."
Plain-English Meaning: Failure to perform at least one test to verify the identity of every incoming dietary ingredient or raw component before use, or relying on a supplier's Certificate of Analysis (COA) without first qualifying the supplier.
Standard CAPA Remediation Path: Establish SOP-QA-004 requiring FTIR/HPLC/organoleptic identity testing on 100% of incoming dietary ingredient lots and annual audit + 3-lot confirmatory testing before relying on any vendor COA.