Key facts
| Firm | JKR Pharmacy Ventures, LLC |
|---|---|
| FEI / inspection ID | 3033262505 |
| Inspection end date | December 19, 2025 |
| Citation count | 9 |
Citations explained
Observation 1 — Aseptic process ing areas are deficient regard ing the system for monitoring
Aseptic process ing areas are deficient regard ing the system for monitoring environmental conditions. Specifically, A.Your fnm is n ot perfo1ming enviro nmental or personnel monitoring in the classified areas (ISO ij lISO r.l) each day that sterile dmgs products are produced. Viable surface sampling, viable active air sampling, and nonviable a ir sampling are perfo1med [(6) (4) Iwhen your rooms and hoods are re-ce1iifi ed . In addition, your fnm does not peifo1m non-viabl e pa1iiculate monitoring in the ISOQ workstations during the production of sterile diug products. Fmi he1more, the action limit specifications (ISO Class 4 (b) ( ) colony fo1ming units per contact plate (cful ><') cm2) u sed for Inicrobiological evaluation of airborne and surface bacteria are n ot adequate for I S O □ classified areas, and there is no ass urance that the ISO r.1 classified areas are tested under dynainic conditions. B.Your fnm is not monitoring each technician working in the ISO ~.
Observation 2 — Procedures designed to prevent microbiological contamination of diug products pmp o1ting to
Procedures designed to prevent microbiological contamination of diug products pmp o1ting to be sterile did not inclu de validation of the aseptic and sterilization process. Specifically, A. Media fills or aseptic process simulations perfo 1med do n ot closely simulate actual production conditions or cover worst case conditions. Your fnm fails to simulate actual production conditions in eve1y . container type during media fills, including vials, di·optainers, syringes, and bags. Cu~[:TTenthL._ your techniciap naim acists fill media into a total or'<"H•i vials (consisting of Dvials at (b) (4) an i<"H•i vials a;l(D) (4~wit~ (D) l (4) positive control vial s. However, during routine production ~your 1 fnm fills various size vials (b) {4) Iand [(t5) (4Ji vials), di·op tainer bottles ~(D) (4)/'H• EM PLOYE E($) SIGNATURE DATE lSSUEO SEE REVERSE Lisa R Hilliard, I nvestigat o r = 1 2 /1 9/ 2 0 25 OF THIS PAGE U&aR t«nan:I &,:U&a R.t91ard ·S X : ~ : 12· l 9--2025.
Observation 3 — Procedures designed to prevent microbiological contamination of diug products pmp o1ting to
Procedures designed to prevent microbiological contamination of diug products pmp o1ting to be sterile are not estab li shed, written and fo ll owed. Speci fi ca lly, A.Your fnm has no written procedure fo r how to separate multip le batch preparations to prevent contamination or ffilX -UpS during the production of sterile di11g products. On [(6) (4) I, [(b) (4 ) Ipreparation of ingredien ts were per fo1med fo r 4 (b) < l diug products, Estradiol Cypionate (ECP) Injection 10 mg/mL (Lot 121025B.37, BUD 01/24/2026), Acetylcysteine Injection Solution (PF) 200 mg/mL (Lot 121025F.57, BUD 01/24/2026), Iso fl up redone Acetate Injection Suspension 2 mg/mL (Lot 121025C.29, BUD 01/24/2026), Guanabenz Acetate Injection 20 mg/mL (Lot EMPLOYE E($) SIGNATURE DATE lSSUEO SEE REVERSE Lisa R Hilliard, Investigat o r OF THIS PAGE X = 1 2/ 1 9/2025 U&aR t«nan:I &,:U&aR.t91ard ·S : ~ : 12· l 9--2025 11 02 PAGE 4 ofll PAGES F ORM FDA 483 (09/08).
Observation 4 — Written procedures are lacking which describe in sufficient detail the receipt, identification
Written procedures are lacking which describe in sufficient detail the receipt, identification, sampling, testing and approval of components. Specifically, A. Your fnm does not perfo1m microbiological testing for purchased [(15) (4 )] water used to produce non-sterile dmg products. Your fnm fails to ensure that the purchased [(6) -(4 water meets specifications for [(6) -(4)) Water, USP, pha1maceutical use. Non-sterile diug products produced using !(b) (4 )i water include EPM Oral Suspension (Sulfadiazine and Pyrimethamine) 3 3 3 mg/ml and 16.67 mg/ml, Penicillin/Gelatin Gutteral Pouch Infusion 250,000 units/mL, Chloramphenicol Ophthalmic Ointment I%, and Tris EDTA Solution. B.Your fnm uses a store-brand liquid detergent to clean hand wash glassware, utensils and other supplies used to compound non-sterile and non-sterile diug products. Your fnm failed to justify the use of a non-phaimaceutical-grade cleaning agent for product-contact equipment and failed to demonstrate that such practices do not adversely affect diug quality. C.Your fnm uses [(b) (4) Iduring the production of non-sterile di11g products.
Observation 5 — Personnel were observed touching equipment or other s urfaces located outside of
Personnel were observed touching equipment or other s urfaces located outside of the ISO ar ea with gloved hands and then proceeding with aseptic processing without changing or sanitizing gloves. Q Specifically, on [(6) -(4) I, during the production of Diclofenac Ophthalmic Ointment 0.1% (Lot 121025D.06, BUD 01/24/2026), yo ur fnm 's sterile compounding technician picked up a balance foot that fell on the fl oor while wearing sterile gloves. The balance was wip ed and the gloves were sprayed with ((b) (4 ) 1- Your phaim acy technician returned to aseptically filling the diug product without changing gloves. The di11g product, Diclofenac Ophthalmic Ointment 0.1 % (Lot 121025D.06, BUD 01 /24/2026), was dispensed as office stock on 12/10/2025.
Observation 6 — Testing and release of di11g product fo r distribution do not include
Testing and release of di11g product fo r distribution do not include appropriate laborato1y dete1mination of satisfacto1y confo1mance to the identity and strength of each active ingredient prior to release. Speci fi cally, A.Your fnm does not conduct routine testing fo r potency (ass ay) fo r all diug products produced by your fnm , including both sterile and non-sterile. B.Your fnm does not conduct routine testing of all of your di11g products label ed as sterile fo r sterility and/or endotoxin prior to release and distribution. EMPLOYE E($) SIGNATURE DATE lSSUEO SEE REVERSE Lis a R Hilli ar d , Investig a to r THIS PAGE = 1 2/ 1 9/202 5 OF U&aR t«nan:I &,:U&a R.t91ard ·S X : ~ : 12· l 9--2025 11 02 F ORM FDA 483 (09/08)
Observation 7 — Repo1is of analysis from component suppliers are accepted in lieu of testing
Repo1is of analysis from component suppliers are accepted in lieu of testing each component for conformity with all appropriate written specifications, without establishing the reliabi li ty of the supplier 's analyses through appropriate validation of the supplier's test results at appropriate interva ls. Specifica lly, your fnm produces sterile and non-sterile drng products using bulk diug substances, excipients, and other materials but does not peif01m any testing, including an identity test, on the incoming bulk di11g substances or excipients used to produce these diug products. Cunently, your fnm accepts glycerin as an excipient or ingredient for various fo1mu las administered orally without ensuring that the ingredient is tested for Diethylene Glycol (DEG) and Ethylene Glycol (EG) contamination. For exampl e, Omeprazole & Cimetidine Oral Suspension 114 mg/mL & 50 mg/mL (Lot 093025AC. l 7, BUD 12 /29/2025) was produced using Glycerin 99% USP (Lot [(6) -(4)I, expiration [(6) (4) I). Your fnm received the ce1iificate of analysis (COA) for.
Observation 8 — There is no written testing program designed to assess the stability characteristics
There is no written testing program designed to assess the stability characteristics of diug products. Specifically, Your fnm does not have a written stability testing program to dete1mine Beyond Use Dates (BUD) placed on all your diug products. Your fnm has no written and approved stability protocols and no final written and approved repo1is. In addition, your fnm has not perfo1med container closure integrity testing. For example, the diug product Detomidine HCl & Xylazine Injection 20 mg/ml & 10 mg/ml EMPLOYE E($) SIGNATURE DATE lSSUEO SEE REVERSE Lisa R Hilliard, I nvestigat o r 12 /1 9/ 2025 OF THIS PAGE
Observation 9 — The responsibilities and procedures applicable to the quality control unit are not
The responsibilities and procedures applicable to the quality control unit are not in writing and fully fo llowed. A.Your fnm has no written procedures fo r the responsibi li ties of the Qua li ty Unit, including release or rejection of the finished animal diug products. B.Your fnm lacks written procedures fo r the management and handling of investigation of unexplained discrepancies whether or not the compoun de d lot has been a h-eady distributed and failed to adequately investigate environmental monitoring excursions fo llowing the sterile compounding ar ea room rece1ii fi cations in October 2025. Unacceptable microor ganism concentrations we re repo1ied fo r air samples collected from four locations in the common preparation area (ISO !!I classi fi cation). Total colony fo1ming units ( cfu, action level 4 r H J cfu) were repo1ied fo r location qj (9 cfu), cQ (9 cfu), cQ (13 cfu), and cQ (20 cfu), and the colonies we re identi fi.
What a Form 483 means
A Form FDA 483 is issued at the close of an FDA facility inspection to list conditions an investigator observed that may violate the Federal Food, Drug, and Cosmetic Act or its implementing regulations. It reflects the investigator's professional judgment at that point in time and is not a final agency determination, an enforcement action, or proof that a violation occurred. Firms are expected to respond in writing, typically within 15 business days, describing the corrective and preventive actions they plan to take. FDA reviews that response, along with any follow-up evidence, before deciding what happens next. Many 483s are resolved through corrective action alone. When FDA judges a firm's response inadequate, or when the underlying conditions are serious enough, the observations documented here can lead to a Warning Letter or further regulatory action. This page presents the observations exactly as recorded on the FDA-issued document; always confirm citation language against the original record before relying on it.
JKR Pharmacy Ventures, LLC’s FDA history
Argus HQ has recorded 1 total FDA action tied to JKR Pharmacy Ventures, LLC: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.
Frequently asked questions
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3033262505.
- Is a Form 483 the same as a Warning Letter?
- No. A Form 483 lists an FDA investigator’s observations at the close of an inspection; it is not a final agency determination. FDA may or may not follow up with a Warning Letter depending on the firm’s response and the severity of the findings.
- Where can I read the full Form 483?
- The verbatim inspection record is the source of truth — always confirm citation language against the original FDA document before acting.
- What is an FDA Form 483?
- A Form FDA 483 lists an FDA investigator's written observations at the close of a facility inspection, issued under section 704(b) of the Federal Food, Drug, and Cosmetic Act. It documents conditions the investigator judged may violate FDA regulations. A 483 is not an enforcement action or a final determination that a violation occurred.
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Related enforcement actions
Full FDA history for JKR Pharmacy Ventures, LLCCompiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2025). JKR Pharmacy Ventures, LLC — FDA Form 483 Inspection, December 19, 2025 (9 Citations). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-jkr-pharmacy-ventures-llc-2025-12-19-3033262505
"JKR Pharmacy Ventures, LLC — FDA Form 483 Inspection, December 19, 2025 (9 Citations)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-jkr-pharmacy-ventures-llc-2025-12-19-3033262505.
Argus HQ Research. "JKR Pharmacy Ventures, LLC — FDA Form 483 Inspection, December 19, 2025 (9 Citations)." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-jkr-pharmacy-ventures-llc-2025-12-19-3033262505.
@misc{argushq_argushq_ai_483_fda_483_jkr_pharmacy_ventures_llc_2025_12_19_3033262505_2025,
title = {JKR Pharmacy Ventures, LLC — FDA Form 483 Inspection, December 19, 2025 (9 Citations)},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-jkr-pharmacy-ventures-llc-2025-12-19-3033262505},
note = {Accessed: July 15, 2026}
}