Form FDA 483 · Issued 2026-01-16
Regeneron Pharmaceuticals, Inc. — FDA Form 483 Analysis
FEI: 3015581066 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Drug Product Manufacturer) · Lead Investigator: Sarah J. Lindqvist
FDA Form 483 issued to Regeneron Pharmaceuticals, Inc. (FEI 3015581066) on 2026-01-16 following an inspection of its drug product manufacturer operations in New York. The report documents 5 inspection observations centered on Electronic Record Data Integrity (21 CFR Part 11) & Retention, Master Manufacturing & Batch Production Records (MMR/BPR).
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Observation-by-Observation 21 CFR Breakdown (5)
Observation #1 · 21 CFR 211.48(a)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Plumbing System Defects
Inspector Observation Language: "The plumbing system contains defects that could contribute to the contamination of drug products. Specifically, observed during inspection of Regeneron Pharmaceuticals, Inc. on 2026-01-16."
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 211.100(a)
Master Manufacturing & Batch Production Records (MMR/BPR)
REPEAT CITATION AT FACILITY
Changes to Procedures Not Reviewed, Approved
Inspector Observation Language: "Changes to written procedures are not [drafted, reviewed and approved by the appropriate organizational unit] [reviewed and approved by the quality control unit]. Specifically, observed during inspection of Regeneron Pharmaceuticals, Inc. on 2026-01-16."
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.
Observation #3 · 21 CFR 211.160(a)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Deviations from laboratory control requirements
Inspector Observation Language: "Deviations from written [specifications] [standards] [sampling plans] [test procedures] [laboratory mechanisms] are not [recorded] [justified]. Specifically, observed during inspection of Regeneron Pharmaceuticals, Inc. on 2026-01-16."
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 211.68(b)
Equipment Qualification (IQ/OQ/PQ), Calibration & Water Systems
FIRST-TIME OBSERVATION
Written record not kept of program and validation data
Inspector Observation Language: "A written record of the program along with appropriate validation data has not been maintained in situations where backup data is eliminated by computerization or other automated processes. Specifically, observed during inspection of Regeneron Pharmaceuticals, Inc. on 2026-01-16."
Plain-English Meaning: Scales, thermometers, pH meters, autoclaves, or purified water systems lacking current NIST-traceable calibration or process validation.
Standard CAPA Remediation Path: Tag all critical measuring instruments with calibration due dates, lock out overdue devices, and perform weekly TOC/conductivity/bioburden testing on purified water loops.
Observation #5 · 21 CFR 211.160(b)(2)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
In-process samples representative, identified properly
Inspector Observation Language: "Samples taken of in-process materials for determination of conformance to specifications are not [representative] [properly identified]. Specifically, observed during inspection of Regeneron Pharmaceuticals, Inc. on 2026-01-16."
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.