Form FDA 483 · Issued 2026-03-04
Fresh & Ready Foods LLC — FDA Form 483 Analysis
FEI: 3003328123 · Sector: Food & Beverage (Manufacturer) · Lead Investigator: Rebecca M. Okafor
FDA Form 483 issued to Fresh & Ready Foods LLC (FEI 3003328123) on 2026-03-04 following an inspection of its manufacturer operations in California. The report documents 4 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, Supplier Qualification & Foreign Supplier Verification (FSVP).
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 111.105(a)
Incoming Ingredient Identity Testing & COA Qualification
REPEAT CITATION AT FACILITY
Quality control - processes, specifications, written procedures
Inspector Observation Language: "Your quality control personnel did not approve or reject [processes] [specifications] [written procedures] [controls] [tests] [examinations] [deviations or modifications] that may affect the identity, purity, strength, or composition of a dietary supplement. Specifically, observed during inspection of Fresh & Ready Foods LLC on 2026-03-04."
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 #2 · 21 CFR 117.405(a)(1)
Supplier Qualification & Foreign Supplier Verification (FSVP)
FIRST-TIME OBSERVATION
Supply-chain program - Establish
Inspector Observation Language: "You did not establish a written supply-chain program. Specifically, observed during inspection of Fresh & Ready Foods LLC on 2026-03-04."
Plain-English Meaning: Failure to develop or maintain a Foreign Supplier Verification Program (FSVP) or approved vendor qualification file verifying that raw material suppliers meet U.S. FDA safety standards.
Standard CAPA Remediation Path: Maintain an Approved Supplier List (ASL) with hazard analysis, third-party GMP audit certificates, and FSVP importer identification for every foreign ingredient.
Observation #3 · 21 CFR 108.35(g)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
FIRST-TIME OBSERVATION
Approved school
Inspector Observation Language: "Operators of [retorts] [thermal processing systems] [aseptic processing and packaging systems] [container closure inspections] were not under the operating supervision of a person who attended and satisfactorily completed a school approved by the FDA Commissioner. Specifically, observed during inspection of Fresh & Ready Foods LLC on 2026-03-04."
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 #4 · 21 CFR 111.365(i)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Metal, foreign material
Inspector Observation Language: "You did not use effective measures to protect against the inclusion of metal or other foreign material in [components] [dietary supplements]. Specifically, observed during inspection of Fresh & Ready Foods LLC on 2026-03-04."
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.