Form FDA 483 · Issued 2026-02-26
Biograft Transplant Services Inc — FDA Form 483 Analysis
FEI: 3001238010 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Tissue Recovery Establishment) · Lead Investigator: Sarah J. Lindqvist
FDA Form 483 issued to Biograft Transplant Services Inc (FEI 3001238010) on 2026-02-26 following an inspection of its tissue recovery establishment operations in Texas. The report documents 5 inspection observations centered on Finished Product Testing, Stability & Expiration Dating, Incoming Ingredient Identity Testing & COA Qualification.
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Observation-by-Observation 21 CFR Breakdown (5)
Observation #1 · 21 CFR 211.186(b)(9)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Complete instructions, procedures, specifications et. al.
Inspector Observation Language: "Master production and control records lack [complete manufacturing and control instructions] [sampling and testing procedures] [specifications] [special notations] [precautions to be followed]. Specifically, observed during inspection of Biograft Transplant Services Inc on 2026-02-26."
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 212.60(d)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Supplies adequately controlled
Inspector Observation Language: "Your [identity] [purity] [quality] of [reagents] [solutions] [supplies] used in your testing procedures are not adequately controlled. Specifically, observed during inspection of Biograft Transplant Services Inc on 2026-02-26."
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 #3 · 21 CFR 211.25(b)
Incoming Ingredient Identity Testing & COA Qualification
REPEAT CITATION AT FACILITY
Supervisor Training/Education/Experience
Inspector Observation Language: "Individuals responsible for supervising the [manufacture] [processing] [packing] [holding] of a drug product lack the [education] [training] [experience] to perform their assigned functions in such a manner as to assure the drug product has the safety, identity, strength, quality and purity that it purports or is represented to possess. Specifically, observed during inspection of Biograft Transplant Services Inc on 2026-02-26."
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 211.42(c)(10)(i)
Cleaning Validation, Sanitation Logs & Pest Control
FIRST-TIME OBSERVATION
Floors, walls, ceiling surfaces
Inspector Observation Language: "Aseptic processing areas are deficient in that [floors] [walls] [ceilings] are not smooth and/or hard surfaces that are easily cleanable. Specifically,observed during inspection of Biograft Transplant Services Inc on 2026-02-26."
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 #5 · 21 CFR 211.122(a)
Label Control, Undeclared Allergens & Structure/Function Claims
FIRST-TIME OBSERVATION
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 Biograft Transplant Services Inc on 2026-02-26."
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.