Key facts
| Firm | Mixlab WI LLC |
|---|---|
| FEI / inspection ID | 3005946041 |
| Inspection end date | July 24, 2025 |
| Citation count | 7 |
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 — The responsibilities and procedures applicable to the quality control unit are not
The responsibilities and procedures applicable to the quality control unit are not fully followed. Specifically, A. The written procedure, SOP MLWl-001-04, titled' on-Sterile Compounding Area", Revision 2.0, is not consistently followed. As specified in Section 3.9.1, the minimum garb required to enter the compounding area includes a reusable lab coat, shoe covers, Hair/bear net, and N95 mask or respirator. When gown~d, they must remain within the compounding area and may only be reused during the ,..., However, employees were observed donning gloves and shoe covers upon entry throug . the ack door, proceeding through the compounding area to the basement to put on their gowns, and then re-entering the compounding area. B. The written procedure, SOP J\1L WI-001-05, titled "Non-Sterile HD Compounding Area," Revision 2.0, is not always followed. As specified in Section 3.3, non-sterile hazardous drug (HD) compounding and HD storage must occur in a Containment Segregated Compounding Area (C-SEC) that is separate from non-HD compounding and/or non-HD storage..
Observation 2 — The master production and control records are not followed
The master production and control records are not followed. Specifically, EMPI..OYEE(S ) SIGNAT\JRE SEE Muna Algharibeh, I nvestigator ).,l.A. 07/24/2025 REVERSE OF Tiffani Tur;i.n sk i , Veter inary THIS PAGE Medical Off i cer Andy J . Bar rowcliff , Branch Chief ~ FORM FDA 4&3 (09/08) PREVIOUS.EDmON Oll$0l.Elll
Observation 3 — Batch production and control records do not include complete information relating to
Batch production and control records do not include complete information relating to the production and control of each batch. Specifically, Your firm's batch records do not include docwnentation and/or complete documentation of each significant step in the production of drug products. For example, Your finn compounds Methimazole 2.5mg/0. l mL Transdermal and fills it into a ~ syringe. The CJ syringe is then used to fill Metbimazo1e 2.5mg/0. lmL Transdermal into lmL, 3mL, 6mL, and 9mL pens. The following was observed upon review of the manufacturing batch record for Methimazole EMP LOYEE(S) SI GNA~ SEE Muna Al gharibeh , Invest igator /v( .ft. 07/2 4 /2025 REVERSE OF Tiffani Turins ki , Veterinary • THIS PAGE Medical Office r Andy J . Barrowcliff , Branch Chief
Observation 4 — Written procedures are not established for the cleaning and maintenance of equipment
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture processing, packing or holding of a drug product. Specifically, claim. Your finn did not conduct an in-house efficacy study to verify the sporicidal product's label Instead, the adequacy of the cleaning agent for its intended use was determined based on a review of the efficacy study provided by the cleaning agent manufacturer.
Observation 5 — Testing and release of drug product for distribution do not include appropriate
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release. Specifically, EMPLOYEE(S) SIG NATURE SEE Muna Algharibeh , Investi g ator /J..·A· 07/24/2025 REVERSE OF Ti ffa n i Tur inski, Veterinary THIS PAGE Medical Officer Andy J . B arrowcl iff , Branch Chief ~~ 5PAGES
Observation 6 — Specific identification tests are not conducted on components that have been accepted
Specific identification tests are not conducted on components that have been accepted based on the supplier's report of analysis. Specifically, A certificate of analysis from the supplier is accepted in lieu of testing of each component received. The firm currently neither is testing each component, including excipient and active ingredient, nor has a program to establish the reliability of the supplier.
Observation 7 — 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 drug products. Specifically, Your firm does not have a written stability testing program to determine Beyond Use Dates (BUD) placed on all your drug product. SEE REVERSE OF THIS PAGE EMPLOYEE(S) SIGW\ TURE Muna Algharibeh , Investigator Tiffani Turinski , Veterinary Medical Officer Andy J . Barrowcliff, Branch Chief ~ ,A,,I _/ /_ AA "ti" -~ . ......... I ~ A.A- 07/24/2025 FORM FJ>A 483 (09/08) PREVTO~ EDmON OOSOLETE
Mixlab WI LLC’s FDA history
Argus HQ has recorded 1 total FDA action tied to Mixlab WI LLC: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.
Frequently asked questions
- Has Mixlab WI LLC had other FDA inspection citations?
- This is the only FDA action Argus HQ has on file for Mixlab WI LLC so far. Argus ingests new FDA records daily.
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3005946041.
- 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.
See if this 483 escalates to a warning letter — before your auditor asks.
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Related enforcement actions
Full FDA history for Mixlab WI 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: Mixlab WI LLC, July 24, 2025 — 7 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-mixlab-wi-llc-2025-07-24-3005946041
"Form 483 Record: Mixlab WI LLC, July 24, 2025 — 7 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-mixlab-wi-llc-2025-07-24-3005946041.
Argus HQ Research. "Form 483 Record: Mixlab WI LLC, July 24, 2025 — 7 Citations." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-mixlab-wi-llc-2025-07-24-3005946041.
@misc{argushq_argushq_ai_483_fda_483_mixlab_wi_llc_2025_07_24_3005946041_2025,
title = {Form 483 Record: Mixlab WI LLC, July 24, 2025 — 7 Citations},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-mixlab-wi-llc-2025-07-24-3005946041},
note = {Accessed: July 15, 2026}
}