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 Fagron Compounding Services 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 Fagron Compounding Services had other FDA inspection citations?

Yes. Argus HQ has recorded 6 total FDA actions tied to Fagron Compounding Services, including 1 Form 483 inspection citation.

FDA Inspects Fagron Compounding Services: Form 483 with 3 Citations (August 8, 2025)

Key facts

Firm	Fagron Compounding Services
FEI / inspection ID	3012104093
Inspection end date	August 8, 2025
Citation count	3

In short: FDA inspected Fagron Compounding Services in Kansas and issued a Form 483 listing 3 inspectional observations following an inspection that concluded 2025-08-08. FDA records classify Fagron Compounding Services 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.

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 — There is a failure to thorough ly review any unexplained discrepancy and

There is a failure to thorough ly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been ah-eady distributed. Specifically, Inadequate investigations were noted during the 2024 FDA inspection. A. Since September 2024, you fom has documented 14 sterility positive investigations for products tested in your microbiology laborato1y. Four sterility positive investigations were for product made at your Canton, MA, facility, while 10 investigations were for product made at the Wichita, KS, facility. Your fom has open ed multiple action items and coITective and preventative actions to address the sterility positive events and identified multiple potential root causes to include deficiencies with the sterility testing b) (4) I systems and inad equate material disinfection during production activities as documented in action items AI -2025-0268,

Observation 2 — Buildings u sed in the manufacturing, processing, packing and holding of a

Buildings u sed in the manufacturing, processing, packing and holding of a drng product are n ot maintained in a good state of repair. Specifically, Your fnm does not maintain production areas and associated equipment adequately. The following were noted during the inspection on 7/29/2025 and 7/30/2025: • Unknown black discoloration within the ISO-5 area of the fill hood for Fill Lin ('.] • What appeared to be rnst on a cart holding scale calibration weights u sed for comp ounding (ISO-8). • What appeared to be rnst on fasteners/bolts within ISO-7 material passthroughs in rooms 323 and 340. • Dark m:eenish fuzzy spots were observed on the light fixtures and status tag of cold room '.i6Jl4j' [(6)_ 41.J , which is utilized to store retain samples and finish ed product before distribution. Units from Vancomycin HCl in sodium chloride injection IV bags fr om lo{(b (4) I (Expiiy l 1/17/2025) were observed in the room.

Observation 3 — The number of qualified personnel is inadequate to p erfo1m the manufacture

The number of qualified personnel is inadequate to p erfo1m the manufacture of each diug product. Specifically,

Fagron Compounding Services’s FDA history

Argus HQ has recorded 6 total FDA actions tied to Fagron Compounding Services: 0 warning letters, 5 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 Fagron Compounding Services 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 Fagron Compounding Services had other FDA inspection citations?: Yes. Argus HQ has recorded 6 total FDA actions tied to Fagron Compounding Services, including 1 Form 483 inspection citation.

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Full FDA history for Fagron Compounding Services

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 (2025). FDA Inspects Fagron Compounding Services: Form 483 with 3 Citations (August 8, 2025). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-fagron-compounding-services-2025-08-08-3012104093

MLA

"FDA Inspects Fagron Compounding Services: Form 483 with 3 Citations (August 8, 2025)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-fagron-compounding-services-2025-08-08-3012104093.

Chicago

Argus HQ Research. "FDA Inspects Fagron Compounding Services: Form 483 with 3 Citations (August 8, 2025)." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-fagron-compounding-services-2025-08-08-3012104093.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_fagron_compounding_services_2025_08_08_3012104093_2025,
  title = {FDA Inspects Fagron Compounding Services: Form 483 with 3 Citations (August 8, 2025)},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-fagron-compounding-services-2025-08-08-3012104093},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗