Form FDA 483 · Issued 2026-03-12
Custom Analytics LLC — FDA Form 483 Analysis
FEI: 3003261962 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Contract Testing Laboratory) · Lead Investigator: David K. Chen
FDA Form 483 issued to Custom Analytics LLC (FEI 3003261962) on 2026-03-12 following an inspection of its contract testing laboratory operations in South Carolina. The report documents 4 inspection observations centered on Finished Product Testing, Stability & Expiration Dating, Electronic Record Data Integrity (21 CFR Part 11) & Retention.
Get Full Annotated 483 Dossier + CAPA Checklist
Instant PDF + CFR Matrix ($79 vs. Redica's $289)
Need Help Fixing These 4 Citations?
Get matched with a vetted 21 CFR remediation consultant
Observation-by-Observation 21 CFR Breakdown (4)
Observation #1 · 21 CFR 211.165(f)
Finished Product Testing, Stability & Expiration Dating
REPEAT CITATION AT FACILITY
Failing drug products not rejected
Inspector Observation Language: "Drug products failing to meet established [standards] [specifications] [quality control criteria] are not rejected. Specifically, observed during inspection of Custom Analytics LLC on 2026-03-12."
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 314.81(b)(2)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Timely submission
Inspector Observation Language: "An annual report was not submitted [each year] [within 60 days of the anniversary date of U.S. approval of the application] to the FDA division responsible for reviewing the application. Specifically, observed during inspection of Custom Analytics LLC on 2026-03-12."
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 · FDCA 503B(a)(10)(A)
Label Control, Undeclared Allergens & Structure/Function Claims
FIRST-TIME OBSERVATION
Drug product labels, fails to include
Inspector Observation Language: "The labels of your outsourcing facility's drug products do not include information required by section 503B(a)(10)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act). Specifically, observed during inspection of Custom Analytics LLC on 2026-03-12."
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 #4 · 21 CFR 211.188(b)(2)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Identification of Equipment and Lines
Inspector Observation Language: "The batch production and control records are deficient in that they do not include the identity of major [equipment] [lines] used. Specifically, observed during inspection of Custom Analytics LLC on 2026-03-12."
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.