Form FDA 483 · Issued 2026-02-06
Tarmac Products, Inc — FDA Form 483 Analysis
FEI: 1025483 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Contract Manufacturer) · Lead Investigator: Elena R. Rostova
FDA Form 483 issued to Tarmac Products, Inc (FEI 1025483) on 2026-02-06 following an inspection of its contract manufacturer operations in Florida. The report documents 3 inspection observations centered on Finished Product Testing, Stability & Expiration Dating, Label Control, Undeclared Allergens & Structure/Function Claims.
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Observation-by-Observation 21 CFR Breakdown (3)
Observation #1 · 21 CFR 211.42(c)(9)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Control / Lab Operations Area
Inspector Observation Language: "Separate or defined areas to prevent contamination or mix-ups are deficient regarding laboratory controls and operations. Specifically, observed during inspection of Tarmac Products, Inc on 2026-02-06."
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 211.125(f)
Label Control, Undeclared Allergens & Structure/Function Claims
FIRST-TIME OBSERVATION
Procedures Written and Followed
Inspector Observation Language: "Procedures describing in sufficient detail the controls employed for the issuance of labeling are not [written] [followed]. Specifically, observed during inspection of Tarmac Products, Inc on 2026-02-06."
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 #3 · 21 CFR 211.84(d)(6)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Objectionable microbiological contamination
Inspector Observation Language: "Each lot of a [component] [drug product containers] [closures] liable to objectionable microbiological contamination is deficiently subjected to microbiological tests before use. Specifically, observed during inspection of Tarmac Products, Inc on 2026-02-06."
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.