Form FDA 483 · Issued 2026-03-05
American Regent, Inc. — FDA Form 483 Analysis
FEI: 3003433784 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Control Testing Laboratory) · Lead Investigator: Sarah J. Lindqvist
FDA Form 483 issued to American Regent, Inc. (FEI 3003433784) on 2026-03-05 following an inspection of its control testing laboratory operations in Ohio. The report documents 5 inspection observations centered on CAPA, Out-of-Specification (OOS) & Complaint Investigations, Cleaning Validation, Sanitation Logs & Pest Control.
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Observation-by-Observation 21 CFR Breakdown (5)
Observation #1 · 21 CFR 211.198(a)
CAPA, Out-of-Specification (OOS) & Complaint Investigations
FIRST-TIME OBSERVATION
Procedures to be written and followed
Inspector Observation Language: "Procedures describing the handling of all written and oral complaints regarding a drug product are not [established] [written] [followed]. Specifically, observed during inspection of American Regent, Inc. on 2026-03-05."
Plain-English Meaning: Failure to thoroughly investigate unexplained batch discrepancies, Out-of-Specification lab results, or consumer complaints/adverse events and document root-cause Corrective and Preventive Actions (CAPA).
Standard CAPA Remediation Path: Deploy a closed-loop CAPA and OOS investigation SOP requiring root-cause determination within 30 business days, impact assessment on distributed lots, and effectiveness checks.
Observation #2 · FDCA 501(a)(2)(A)
Cleaning Validation, Sanitation Logs & Pest Control
FIRST-TIME OBSERVATION
Production areas, difficult to clean/particle generating
Inspector Observation Language: "Production areas have difficult to clean or contain porous, particle generating, or visibly dirty equipment or surfaces. Specifically, observed during inspection of American Regent, Inc. on 2026-03-05."
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 #3 · 21 CFR 211.80(a)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Procedures To Be in Writing
Inspector Observation Language: "Written procedures are lacking which describe in sufficient detail the [receipt] [identification] [storage] [handling] [sampling] [testing] [approval] [rejection] of [components] [drug product containers] [closures]. Specifically, observed during inspection of American Regent, Inc. on 2026-03-05."
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 211.166(a)(2)
Finished Product Testing, Stability & Expiration Dating
REPEAT CITATION AT FACILITY
Stability sample storage conditions described
Inspector Observation Language: "The written stability program for drug products does not describe the storage conditions for samples retained for testing. Specifically, observed during inspection of American Regent, Inc. on 2026-03-05."
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 #5 · 21 CFR 211.188(a)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Accurate reproduction
Inspector Observation Language: "The batch production and control records are deficient in that they are not [an accurate reproduction of the appropriate master production or control record] [checked for accuracy, dated, and signed]. Specifically, observed during inspection of American Regent, Inc. on 2026-03-05."
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.