Key facts
| Firm | Medi-Fare Drug Pharmaceutical Compounding LLC |
|---|---|
| FEI / inspection ID | 3009925820 |
| Inspection end date | June 6, 2025 |
| Citation count | 8 |
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.
Citations explained
Observation 1 — Procedures designed to prevent microbiological contamination of drug products purporting to be
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed. Specifically, A. I visually observed contaminated / stained HEPA fi lter affecting ISO 5 hood n addition to hood hood /fland hood &,lso have apparent contamination / stains. To date, no investigation has been pened regarding this apparent contamination. B. You lack a scientifically established qualification process regarding your media fill unit inspect io ns. You have not demonstrated, via training and qualification, that personnel can accurately and repeatedly detect failing units. C. You rejected lot of repacked Proparacaine HCl 0.5 % due to steri le caps coming off of your(b) (4) syringes du.ring production. You documented this via INC-24-014 which records the use o caps lot These caps had not been scientifically evalu ated prior to use to include actions including but not limited to change control, process validation and / or media fills. After this batch rejection, you documented.
Observation 2 — Aseptic processing areas are deficient regarding the system for cleaning and disinfecting
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions. Specifically, A. I observed apparent white colored residue and apparent brown or red colored stains on your work surfaces in your ISO 5 hood The apparent white colored residue is also apparent throughout your ISO 5 environment affecting approximately all hoods The design with th approximate ofyo working surfaces offers hard to c ean surfaces. To date, ~......a investigation has been opened regarding this apparent contamination. B. You have failed to confirm and maintain the cleanliness of your ISO 5 environments. 1. You us ____..,. to generate smoke during you airflow pattern evaluations. You have not performed testing to sup o rt the adequacy of your cleaning procedures for the presence or absence of :.laaa==~ afler you have cleaned and sanitized your ISO 5 environments. 2. I observed cleaning and sanitizing activities usin on 5/ 19/2025 which included ISO 5 hoo I.
Observation 3 — The separate or defined areas and control systems necessary to prevent contamination
The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient. Spe ci fica lly, A The design of your facility allows for operations to include material flows directly between unclassified areas and your ISO 7 sterile compounding room, "Roo ". Specifically, materials flow from your non-classified "Prep Room" to your ISO 7 compounding room , "Roo " and from "Room 'to your non-classified room, "Quarantine Area". Non-classified areas lack continuous monitoring of differential pressures as well as non-viable particles. B. Air pressure differential limit setpoint alarms and alarm delays are not scientifically established nor monitored regarding your ISO 7 room where you prod uce sterile drug product(s). You did not establish real-time setpoint limit alarms according to your written SOPs such that your SOP requires differential pressures of W.C. Your actual alarm limits ar W .C . Furthermore, you established alarm delays of approximately per your electronic monitoring system and / or vendor as.
Observation 4 — Aseptic processing areas are deficient regarding the system for monitoring environmental conditions
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. Specifically, SEE Rob er t J . Ha m, I nves t ig a~or 6/ 6/20 25 REVERSE OF THIS PAGE
Observation 5 — Reports of analysis from component suppliers are accepted in lieu of testing
Reports of analysis from component suppliers are accepted in lieu of testing each component for confonnity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals. Specifically, you have not certified that water is sterile and nonpyrogenic whereby it is accompanied by a valid COA to ensure the reliability of the supplier's Certificate of Analysis. water is used in the production of sterile drug products to include Fentany _._.....__,, , lo bags. REPEAT SEE Robert J . Ham, Investigat or REVERSE OF THIS PAGE F'ORM FDA 48J (09/08) PREVIOUS rorr,re, oesou:rn INSPECTIONAL OBSERVATIONS P AG E40F7rAGES
Observation 6 — Written records of investigations into the failure of a batch or any
Written records of investigations into the failure of a batch or any of its components to m eet specifications do not always include the conclusions and follow-up. Specifically, articulate matter on 5/20/2025 in approximatel syringes which were a part of your media fill lo ___,. These syringes were previously inspected by your furn on 5/07/2025 and 5/15/2025 and were not identified with particulate matter. B. You documented INC-24-024 on 11 /5/2024 for surface regarding ISO 5 hood ~ as observed wi th "overgrowth" of Rhizopus-oryzae. Lot ..___. of Phenylepbrine was rejected. Your root cause was inconclusive, and you did not document additional CAPA actions to address this failure.
Observation 7 — An adequate number of batches of each drug product are not tested
An adequate number of batches of each drug product are not tested to determine an appropriate expiration date. Specifically, You discontinued your stability program in approximately 2018 per your site leadership personnel. You have continued to roduce various drug products to include but not limited to Fentanyl , lot in bags, Succinylcholine , lot m syringes. Succinylc holine is produced jn lots of SEE Robert J. Ham, Investiga t o r - -- ----' 6/ 6/ 202 5 REVERSE OF THIS PAGE FORM FDA-483 (09/N) ,1U;V10\JS fOOlON OBS0LtT£ INSPECTION AL OBSERVATIONS PAGE SOF i PAGES
Observation 8 — Written procedures are not established, written and followed that describe the in-process
Written procedures are not established, written and followed that describe the in-process controls, tests and examinations to be conducted on appropriate samples of in-process materials of each batch. Specifically, A. You lack establishment of scientifically justifiable in-process limits regarding visual inspection. Your limit i Vo, in aggregate for your 100% inspection in addition to your post 100% inspection sample(s). You have not established limits specific to individual defect categories to include but not limited to leakers and particulate matter. You have detected units with fibers and leaking units during your 100% inspection. B. You lack use of adequate equipment[(b) (4) ) regarding visual inspection. You currently utilize 11 backgrounds without adequate lighting. C. You do not comprehensively document your post 100% inspection sample to support the sample is appropriate numerically and that it represents the entire batch. OB SERVATI ON 9 Employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned.
Medi-Fare Drug Pharmaceutical Compounding LLC’s FDA history
Argus HQ has recorded 1 total FDA action tied to Medi-Fare Drug Pharmaceutical Compounding 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: 3009925820.
- 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 Medi-Fare Drug Pharmaceutical Compounding 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). Form 483 Record: Medi-Fare Drug Pharmaceutical Compounding LLC, June 6, 2025 — 8 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-medi-fare-drug-pharmaceutical-compounding-llc-2025-06-06-3009925820
"Form 483 Record: Medi-Fare Drug Pharmaceutical Compounding LLC, June 6, 2025 — 8 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-medi-fare-drug-pharmaceutical-compounding-llc-2025-06-06-3009925820.
Argus HQ Research. "Form 483 Record: Medi-Fare Drug Pharmaceutical Compounding LLC, June 6, 2025 — 8 Citations." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-medi-fare-drug-pharmaceutical-compounding-llc-2025-06-06-3009925820.
@misc{argushq_argushq_ai_483_fda_483_medi_fare_drug_pharmaceutical_compounding_llc_2025_06_06_3009925820_2025,
title = {Form 483 Record: Medi-Fare Drug Pharmaceutical Compounding LLC, June 6, 2025 — 8 Citations},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-medi-fare-drug-pharmaceutical-compounding-llc-2025-06-06-3009925820},
note = {Accessed: July 15, 2026}
}