Form FDA 483 · Issued 2026-01-15
MIDWAY MEDICAL — FDA Form 483 Analysis
FEI: 3015536408 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Specification Developer) · Lead Investigator: Jonathan A. Vance
FDA Form 483 issued to MIDWAY MEDICAL (FEI 3015536408) on 2026-01-15 following an inspection of its specification developer operations in Illinois. The report documents 5 inspection observations centered on Master Manufacturing & Batch Production Records (MMR/BPR), Finished Product Testing, Stability & Expiration Dating.
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Observation-by-Observation 21 CFR Breakdown (5)
Observation #1 · 21 CFR 211.105(a)
Master Manufacturing & Batch Production Records (MMR/BPR)
FIRST-TIME OBSERVATION
Identification of containers, lines, equipment
Inspector Observation Language: "All [compounding and storage containers] [processing lines] [major equipment] used during the production of a batch of drug product is not properly identified at all times to indicate [contents] [the phase of processing of the batch]. Specifically, observed during inspection of MIDWAY MEDICAL on 2026-01-15."
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 #2 · 21 CFR 211.160(b)(2)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Acceptance of in-process materials
Inspector Observation Language: "Determinations of conformance to appropriate written specifications for acceptance are [not made] [deficient] for in-process materials. Specifically, observed during inspection of MIDWAY MEDICAL on 2026-01-15."
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 #3 · 21 CFR 211.80(d)
Incoming Ingredient Identity Testing & COA Qualification
REPEAT CITATION AT FACILITY
Status of Each Lot Identified
Inspector Observation Language: "Each lot of [components] [drug product containers] [closures] was not appropriately identified as to its status in terms of being quarantined, approved or rejected. Specifically, observed during inspection of MIDWAY MEDICAL on 2026-01-15."
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 211.165(d)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Acceptance/Rejection Levels
Inspector Observation Language: "The statistical quality control criteria fail to include appropriate [acceptance levels] [rejection levels]. Specifically, observed during inspection of MIDWAY MEDICAL on 2026-01-15."
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 314.81(b)(1)(ii)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Contamination, chemical or physical change, deterioration
Inspector Observation Language: "An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning [bacteriological contamination] [significant chemical, physical, or other change or deterioration] in a distributed drug product. Specifically, observed during inspection of MIDWAY MEDICAL on 2026-01-15."
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.