Form FDA 483 · Issued 2025-12-19
JKR Pharmacy Ventures, LLC — FDA Form 483 Analysis
FEI: 3033262505 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Producer of Sterile and Non Sterile Drug Products) · Lead Investigator: Jonathan A. Vance
FDA Form 483 issued to JKR Pharmacy Ventures, LLC (FEI 3033262505) on 2025-12-19 following an inspection of its producer of sterile and non sterile drug products operations in Kentucky. The report documents 5 inspection observations centered on Finished Product Testing, Stability & Expiration Dating, Incoming Ingredient Identity Testing & COA Qualification.
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Observation-by-Observation 21 CFR Breakdown (5)
Observation #1 · 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 JKR Pharmacy Ventures, LLC on 2025-12-19."
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 211.194(a)(4)
Incoming Ingredient Identity Testing & COA Qualification
FIRST-TIME OBSERVATION
Data secured in course of each test
Inspector Observation Language: "Laboratory records do not include a complete record of all data secured in the course of each test, including all [graphs] [charts] [spectra] from laboratory instrumentation, properly identified to show the [specific component] [drug product container] [closure] [in-process material] [lot tested] [drug product tested]. Specifically, observed during inspection of JKR Pharmacy Ventures, LLC on 2025-12-19."
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 #3 · 21 CFR 212.10
Personnel GMP Training, Gowning & Hygienic Practices
FIRST-TIME OBSERVATION
Personnel not qualified
Inspector Observation Language: "You lack [a sufficient number of] personnel with the necessary [education] [background] [training] [experience] to perform their assigned functions. Specifically, observed during inspection of JKR Pharmacy Ventures, LLC on 2025-12-19."
Plain-English Meaning: Operators performing manufacturing or QA tasks without documented GMP/SOP training, or observed gowning/hygiene deviations in production rooms.
Standard CAPA Remediation Path: Maintain role-based SOP training matrices signed prior to independent floor assignment and annual cGMP refresher assessments.
Observation #4 · 21 CFR 212.60(g)
Finished Product Testing, Stability & Expiration Dating
FIRST-TIME OBSERVATION
Test records complete (general)
Inspector Observation Language: "Each laboratory used to perform tests related to the production of a PET drug did not keep complete records of all tests performed to ensure compliance with established specifications and standards, including examinations and assays. Specifically,observed during inspection of JKR Pharmacy Ventures, LLC on 2025-12-19."
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 · FDCA 501(a)(2)(A)
Electronic Record Data Integrity (21 CFR Part 11) & Retention
REPEAT CITATION AT FACILITY
Contamination, production area/adjacent areas
Inspector Observation Language: "Contamination was observed in your [production area] [areas adjacent to production areas]. Specifically, observed during inspection of JKR Pharmacy Ventures, LLC on 2025-12-19."
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.