What is the FEI / inspection ID for this Form 483?

FEI / inspection ID: 3012384835.

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.

Form 483 Record: Sincerus Florida, LLC, May 29, 2026

At a glance: FDA inspected Sincerus Florida, LLC in Florida and issued a Form 483 listing 5 inspectional observations following an inspection that concluded 2026-05-29. FDA records classify Sincerus Florida, LLC as a outsourcing facility. A Form 483 documents an investigator's findings at the close of an inspection under the Federal Food, Drug, and Cosmetic Act; it is not a final agency compliance determination. The observations on this page are drawn directly from the FDA-issued Form 483 record. 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.

Key facts

Firm	Sincerus Florida, LLC
FEI / inspection ID	3012384835
Inspection end date	May 29, 2026
Citation count	5

Citations explained

Observation 1 — Procedures designed to prevent microbiological contamination of drug products purporting

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process. Specifically, I) The following deficiencies were identified during the review of the Smoke Visualizati on studies conducted in October 2025 for the!{ill4) JISO 5 Laminar Air Flow Hood (LAF H) (Equipment 10: 00167) in which sterile 2 GM Magnesium Sulfate in 5% Dextrose 50 ml Bag Injection is produced: a. Processes which occur during routine operations, such as sanitizing the Magnesium Sulfate vial stoppers and drawing 4 mL from the vial using a syringe, sanitizing each 5% Dextrose Bag Injection Port, injecting the contents of the syrin ge into the Dextrose bag, and placing an IV seal on each IV port injected, were not simulated during the Dynamic Smoke Study. b. During the Dynamic Smoke Study, th e smoke was positioned away from the t echn ician and the area where the technician was performing operations within the LAFH; as a re su lt, the airflow pattern over the operations could not be visualized. C. The set-up of environmental monitoring (E M) plates and units within the LAFH we re not simulated during the smoke study a

Observation 3 — Acceptance criteria for the sampling and testing conducted by the quality control unit is

Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet appropriate stati stical quality control criteria as a condition for their approval and release. Specifically, The firm 's QuaJity Un it does not perfonn independent Acceptable Quality Limit (AQL) sampling and testing of finished sterile drug products following I 00% manual visual inspection. The firm ' s procedure # SC-03 ·•F inal Visual Inspection of Compounded Sterile Pre parations (CSPs)" does not include instructions for Quality Unit AQL sampling and testing. Without independent AQL testing by the Quality Unit, there is no objective, statistically sound evaluation of whether released product is essentia lly free of visible defects. Specifically, Sterile Drug Product 2 GM Magnesium Sulfate in 5% Dextrose 50 mL Bag Injection Lot 74946 (Compounding Date:~ (4) IBUD: 08JAN2026; Batch Size: '(l>H•i Units) and Lot 7510 I (Compounding Date: [(15) (4) ,; BUD: 24.IAN2026; Batch Size: t:; Un its) were each released following I00% visual inspection perfonned solely by the same compounding technician who produced the respective lots, without an

Observation 4 — Your firm failed to establish adeq uate written procedures for production and process

Your firm failed to establish adeq uate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess. Specifically, The firm ' s procedure# SC-03 "Final Visual Inspection of Compounded Sterile Preparations (CSPs)" does not include instructions for creation and characterization of the defects to be used, including the range of sizes to be used in , and instructions for the qual ification of the Visual Inspection Qualification (defect) f6tt4f Specifical ly , the defectlbH•ldesigned on OSNOV2025 and used to qualify manual visual inspectors is inadequate in that the particulates contained in the defect ti>H•) are of unknown size. No threshold studies (e.g., probability of detection studies) have been performed to determine whether the particulates in the tJ repre se nt the range of defect sizes likely to be encountered in the finished sterile drug product, and whether trained personnel can reproducibly detect them. As a result, there is no scientific basis for concluding that the compounding technician, who was qualified on the '(l>H•> on 06NOV2025, and

Observation 5 — Written procedures are not established and followed for the cleaning and maintenance of

Written procedures are not established and followed for the cleaning and maintenance of eq uipment, including, ut ensils, used in t he manufacture. processing, packing or holding of a drug product. Specifically, The contact times maintained during the cleaning and dis in fec ting of the Cleanroom Suite and the I SO 5 LAFH , used for producing sterile drug product 2 GM Magnesium Sulfate in 5% Dext rose 50 mL Bag Injection Lot 74946 (Compounding Date: [6TT4) '.) and Lot 75 IO I (Compounding D ate: [~4) :J are not documented. The fi rm 's procedure # SC-I7 '·Sterile Compounding Area Cleaning and Disinfecting" specifies a required minimum con tact time o (b (4) for (b )J~ and{b) (4) I and a minimum ofi(b) (4) ffo7,(.!?) (4) Ji( b) (4 ) _ however.the contact times are not recorded in the compounding batch records or cleaning logs and the firm 's procedure SC-17 does not require documentation of the contact time.

Observation 6 — The responsibi li t ies and procedures app li cable to the quality control unit are not

The responsibi li t ies and procedures app li cable to the quality control unit are not in writing or fully followed. Spec ific ally. I) No assessment of retain samples, batch records, and laboratory testing data were conducted at t he time of receipt of the below li sted complaints, as required by the firms procedure# QA - IO ··customer Complaints M anagement" Ste ps 7 .6.1 and 7 .6.3 which states t hat Quality investigates the complaint to determine i f the compounded product may have resulted in a Quality Non-Adverse Event, Adverse Event, or Serious Adverse Event and Quality checks retain samples, batch record, and laboratory testing data for the reported lots, respectively. a. Compla in t# CR25-540 (SKU: 03 1098; Product: Holixia So luti on (Minox idi l 7%/Progesterone 0.1 %; Lot# 7 1065): Pa tient Complaint Description: Getting severe migraines and caus ing scalp to burn/itch. b. Complaint# CR25-389 (S K U: 031098, Product: Hol ixia Soluti on , Lot# 7 1065): Patient Complaint Description: Patient experienced itchiness and redness on the skin/itchy sca lp. c. Complaint# CR25-365 (SKU: 031098; Product: Holixia So lution (Minoxidil ?%/Progesterone 0.1 %; Lot# 7 1065): Patient Com

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.

Sincerus Florida, LLC’s FDA history

Argus HQ has recorded 1 total FDA action tied to Sincerus Florida, 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: 3012384835.
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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Full FDA history for Sincerus Florida, LLC

Compiled 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.

APA

Argus HQ Research (2026). Form 483 Record: Sincerus Florida, LLC, May 29, 2026 — 5 Citations. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/483/sincerus-florida-3012384835-2026-05-29

MLA

"Form 483 Record: Sincerus Florida, LLC, May 29, 2026 — 5 Citations." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/483/sincerus-florida-3012384835-2026-05-29.

Chicago

Argus HQ Research. "Form 483 Record: Sincerus Florida, LLC, May 29, 2026 — 5 Citations." Digital Empire Holdings LLC. Accessed July 29, 2026. https://argushq.ai/483/sincerus-florida-3012384835-2026-05-29.

BibTeX

@misc{argushq_argushq_ai_483_sincerus_florida_3012384835_2026_05_29_2026,
  title = {Form 483 Record: Sincerus Florida, LLC, May 29, 2026 — 5 Citations},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/483/sincerus-florida-3012384835-2026-05-29},
  note = {Accessed: July 29, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗