Form FDA 483 · Issued 2026-02-02
B Positive National Blood Services - Wyoming, LLC. — FDA Form 483 Analysis
FEI: 3023715801 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Source Plasma) · Lead Investigator: Jonathan A. Vance
FDA Form 483 issued to B Positive National Blood Services - Wyoming, LLC. (FEI 3023715801) on 2026-02-02 following an inspection of its source plasma operations in Pennsylvania. The report documents 5 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Master Manufacturing & Batch Production Records (MMR/BPR).
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Observation-by-Observation 21 CFR Breakdown (5)
Observation #1 · 21 CFR 211.84(d)(6)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Objectionable microbiological contamination
Inspector Observation Language: "Each lot of a [component] [drug product containers] [closures] liable to objectionable microbiological contamination is deficiently subjected to microbiological tests before use. Specifically, observed during inspection of B Positive National Blood Services - Wyoming, LLC. on 2026-02-02."
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 #2 · 21 CFR 211.167(a)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Sterility/pyrogen-free testing
Inspector Observation Language: "Each batch of drug product purporting to be [sterile] [pyrogen-free] is not laboratory tested to determine conformance to such requirements. Specifically, observed during inspection of B Positive National Blood Services - Wyoming, LLC. on 2026-02-02."
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 211.188(b)(8)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Labeling Control Records and Label Copies
Inspector Observation Language: "The batch production and control records are deficient in that they do not include [complete labeling control records] [specimen] [copy] of labeling. Specifically, observed during inspection of B Positive National Blood Services - Wyoming, LLC. on 2026-02-02."
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 #4 · 21 CFR 211.196
Electronic Record Data Integrity (21 CFR Part 11) & Retention
REPEAT CITATION AT FACILITY
Distribution Record Requirements
Inspector Observation Language: "Distribution records do not contain the [name and strength of the drug product] [description of dosage form] [name and address of consignee] [date and quantity shipped] [lot or control number of drug product]. Specifically, observed during inspection of B Positive National Blood Services - Wyoming, LLC. on 2026-02-02."
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 211.48(a)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Plumbing System Defects
Inspector Observation Language: "The plumbing system contains defects that could contribute to the contamination of drug products. Specifically, observed during inspection of B Positive National Blood Services - Wyoming, LLC. on 2026-02-02."
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.