Form FDA 483 · Issued 2025-09-12
Donor Services Laboratories Inc - Tampa — FDA Form 483 Analysis
FEI: 3027286748 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Tissue Testing Laboratory) · Lead Investigator: Rebecca M. Okafor
FDA Form 483 issued to Donor Services Laboratories Inc - Tampa (FEI 3027286748) on 2025-09-12 following an inspection of its tissue testing laboratory operations in Florida. The report documents 4 inspection observations centered on Finished Product Testing, Stability & Expiration Dating, Electronic Record Data Integrity (21 CFR Part 11) & Retention.
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Observation-by-Observation 21 CFR Breakdown (4)
Observation #1 · 21 CFR 211.110(b)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
In-process materials specifications testing
Inspector Observation Language: "Examination and testing of samples is not done to assure that in-process materials conform to specifications. Specifically, observed during inspection of Donor Services Laboratories Inc - Tampa on 2025-09-12."
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 211.150(b)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
REPEAT CITATION AT FACILITY
Recall facilitation
Inspector Observation Language: "A system by which the distribution of each lot of drug product can be readily determined to facilitate its recall if necessary, has not been established. Specifically, observed during inspection of Donor Services Laboratories Inc - Tampa on 2025-09-12."
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 #3 · 21 CFR 211.160(b)(3)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Drug products - samples representative, identified properly
Inspector Observation Language: "Samples taken of drug products for determination of conformance to written specifications are not [representative] [properly identified]. Specifically, observed during inspection of Donor Services Laboratories Inc - Tampa on 2025-09-12."
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 #4 · 21 CFR 211.170(b)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Reserve drug product sample quantity - all tests
Inspector Observation Language: "The reserve sample of drug product does not consist of at least twice the quantity necessary to perform all the required tests of drug product. Specifically, observed during inspection of Donor Services Laboratories Inc - Tampa on 2025-09-12."
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.