Form FDA 483 · Issued 2026-02-20
BioLife Plasma Services L.P. — FDA Form 483 Analysis
FEI: 3004582762 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Source Plasma) · Lead Investigator: Jonathan A. Vance
FDA Form 483 issued to BioLife Plasma Services L.P. (FEI 3004582762) on 2026-02-20 following an inspection of its source plasma operations in Indiana. The report documents 5 inspection observations centered on Label Control, Undeclared Allergens & Structure/Function Claims, Master Manufacturing & Batch Production Records (MMR/BPR).
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Observation-by-Observation 21 CFR Breakdown (5)
Observation #1 · 21 CFR 211.122(a)
Label Control, Undeclared Allergens & Structure/Function Claims
REPEAT CITATION AT FACILITY
Sampling/testing of labeling/packaging materials
Inspector Observation Language: "Labeling and packaging materials are not [representatively sampled] [examined] [tested] upon receipt and before use in packaging and labeling of a drug product. Specifically, observed during inspection of BioLife Plasma Services L.P. on 2026-02-20."
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 #2 · 21 CFR 211.182
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Specific information required in individual logs
Inspector Observation Language: "Individual equipment logs do not show [time] [date] [product] [lot number of each batch processed]. Specifically, observed during inspection of BioLife Plasma Services L.P. on 2026-02-20."
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 #3 · 21 CFR 211.110(c)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
In-process materials characteristics testing
Inspector Observation Language: "In-process materials are not tested for [identity] [strength] [quality] [purity] and approved or rejected by the quality control unit [during the production process] [after storage for long periods]. Specifically, observed during inspection of BioLife Plasma Services L.P. on 2026-02-20."
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.
Observation #4 · 21 CFR 211.176
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Failing to test for penicillin cross-contamination
Inspector Observation Language: "Non-penicillin drug products were not tested for the presence of penicillin, when a reasonable possibility existed that a non-penicillin drug product has been exposed to a cross-contamination with penicillin. Specifically, observed during inspection of BioLife Plasma Services L.P. on 2026-02-20."
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 #5 · 21 CFR 211.194(a)(5)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Calculations performed are in the records
Inspector Observation Language: "Laboratory records do not include a record of all calculations performed in connection with the test. Specifically, observed during inspection of BioLife Plasma Services L.P. on 2026-02-20."
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.