Key facts
| Firm | IntegraDose Compounding Services LLC |
|---|---|
| FEI / inspection ID | 3014483112 |
| Inspection end date | July 25, 2025 |
| Citation count | 3 |
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 written and followed. ***Repeat Observation from F DA Inspections ending 09 /19/2018, 08 /02/2021 , and 03 /01/2024*** Specifically, 1) On 7/15/2025, during production of Fentanyl Citrate 2500mcg CADD lot 20250715FEN-l , your production technicians per fo1med the following poor aseptic techniques: a . Finished product vials of Fentanyl Citrate were uncapped within the ISO-7 area prior to filling vials into a pool bag. b. ~~~- One technician in hood b was seen throwing CADD cassette tubing caps from inside the ISO-5 hood to a trashcan located outside of the hood in the ISO-7 envirolllllent. 4.lJ 2) On 7/15/2025, during production of Oxytocin 30U/500mL bag lot 20250715OXY-2, your production technicians perfom1ed the fo llowing poor aseptic techniques: a . One technician in hood [(1:5)(~) I was seen handling product vials in a manner that blocked first pass air over vials that were being drawn up.
Observation 2 — The statistical quality control criteria fail to include appropriate rejection levels
The statistical quality control criteria fail to include appropriate rejection levels. Specifically, Your fmn's 100% visual inspection reinspection AQL evaluation has an acceptance limit that is greater than the acceptance limits set fo r initial 100% visual inspection. The reinspection acceptance limit is not scientifically or statistically justified. Your film released the fo ll owing batches with critical defects identified during reinspection: a)Fentanyl Citrate 2500mcg/50mL in steri le water lot 202409 11 FEN-1, exp i1y 3/ 10/2025, had an initial inspection of 11 critical paiticle defects fo und during 100% inspection. Your fnm opened an investigation and reinspected the lot and found an additional 3 critical paiticle defects. This is above the limit of 4 K t ritical defects fo r reinspection for the batch size, per the production batch
Observation 3 — Employees engaged in the manufacture and processing of a drng product lack
Employees engaged in the manufacture and processing of a drng product lack the training required to perfom1 their assigned functions. Specifica lly, l)Your fnm's visual inspectionU sed during qualification is not representative of the visual inspection process. During visual inspection of a production batch only one cont~(bl < closure system type, size, and product ai·e inspected at a time. Your fnm's visual inspection 41 .ontains units of various container closure systems, sizes, products, and defects. 2)Your fnm does not have a libra1y of defects fr om which on the job traini 6f('fJan be obtained. The only defects available fo r training are defects within the qualification All defects are not present in the visual inspection qualification Rl>l Pl De fe cts missing from )( 4 include critical defects such as missing syringe cap, expired bags used fo r final product, and cracked syringe EMPLOY EE(S) SIGNATURE DATE ISSUED SEE REVERSE Lo ga n T Wi ll ia ms, In ves.
IntegraDose Compounding Services LLC’s FDA history
Argus HQ has recorded 3 total FDA actions tied to IntegraDose Compounding Services LLC: 0 warning letters, 2 recalls, 0 approval records, and 1 Form 483 inspection citation.
Frequently asked questions
- 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.
- Does this Form 483 mean IntegraDose Compounding Services LLC violated the law?
- No. A Form 483 documents an investigator's observations only. FDA reviews the firm's written response and any corrective actions taken before deciding whether further action is warranted, and many 483s are closed without additional enforcement once a firm shows adequate correction.
- What happens after a Form 483 is issued?
- The firm typically has 15 business days to submit a written response describing planned corrections. FDA reviews that response, and unresolved or serious findings can lead to a Warning Letter, import alert, or other enforcement action, though many 483s are resolved without further FDA action.
- Has IntegraDose Compounding Services LLC had other FDA inspection citations?
- Yes. Argus HQ has recorded 3 total FDA actions tied to IntegraDose Compounding Services LLC, including 1 Form 483 inspection citation.
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Related enforcement actions
Full FDA history for IntegraDose Compounding Services 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). FDA Form 483 — IntegraDose Compounding Services LLC (July 25, 2025) — 3 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-integradose-compounding-services-llc-2025-07-25-3014483112
"FDA Form 483 — IntegraDose Compounding Services LLC (July 25, 2025) — 3 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-integradose-compounding-services-llc-2025-07-25-3014483112.
Argus HQ Research. "FDA Form 483 — IntegraDose Compounding Services LLC (July 25, 2025) — 3 Citations." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-integradose-compounding-services-llc-2025-07-25-3014483112.
@misc{argushq_argushq_ai_483_fda_483_integradose_compounding_services_llc_2025_07_25_3014483112_2025,
title = {FDA Form 483 — IntegraDose Compounding Services LLC (July 25, 2025) — 3 Citations},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-integradose-compounding-services-llc-2025-07-25-3014483112},
note = {Accessed: July 13, 2026}
}