Form FDA 483 · Issued 2025-10-17
Charles River Laboratories, Inc — FDA Form 483 Analysis
FEI: 3006500433 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Manufacturer) · Lead Investigator: Rebecca M. Okafor
FDA Form 483 issued to Charles River Laboratories, Inc (FEI 3006500433) on 2025-10-17 following an inspection of its manufacturer operations in Tennessee. The report documents 4 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention.
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Observation-by-Observation 21 CFR Breakdown (4)
Observation #1 · 21 CFR 211.186(b)(2)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Active Ingredient Name and Weight
Inspector Observation Language: "The master production and control records are deficient in that they do not include the [name] [weight] of each active ingredient per dosage unit or unit of weight statement of total weight or measure of any dosage unit. Specifically, observed during inspection of Charles River Laboratories, Inc on 2025-10-17."
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 #2 · 21 CFR 211.46(c)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Exhaust systems inadequate to control air contamination
Inspector Observation Language: "Adequate exhaust systems or other systems to control contaminants are lacking in areas where air contamination occurs during production. Specifically, observed during inspection of Charles River Laboratories, Inc on 2025-10-17."
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 211.101(d)
Incoming Ingredient Identity Testing & COA Qualification
REPEAT CITATION AT FACILITY
Verification of component addition
Inspector Observation Language: "Each component is not added to the batch by one person and verified by a second person.. Specifically, observed during inspection of Charles River Laboratories, Inc on 2025-10-17."
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 211.160(b)(3)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Sampling/testing of drug products
Inspector Observation Language: "The specifications for drug products are deficient in that they do not include a description of the [sampling plan] [testing procedures] for drug products. Specifically, observed during inspection of Charles River Laboratories, Inc on 2025-10-17."
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.