Has Hillyard GMP had other FDA inspection citations?

This is the only FDA action Argus HQ has on file for Hillyard GMP so far. Argus ingests new FDA records daily.

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

FEI / inspection ID: 3009690111.

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.

Hillyard GMP — FDA Form 483 Inspection, February 27, 2026 (1 Citations)

Here's the summary: FDA inspected Hillyard GMP in Missouri, USA and issued a Form 483 listing 1 inspectional observation following an inspection that concluded 2026-02-27. FDA records classify Hillyard GMP as a drug manufacturer. 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	Hillyard GMP
FEI / inspection ID	3009690111
Inspection end date	February 27, 2026
Citation count	1

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 — (QUALITY SYSTEM) Written procedures for the qualification and approval of suppliers of

(QUALITY SYSTEM) Written procedures for the qualification and approval of suppliers of components were not adequately implemented. Specifically, Your firm's SOP QA200-07.02 Vendor Audits effective date 8/19/2020, requires the performance of paper audits as part of supplier qualification. However, paper audits were not conducted for suppliers of components used in the manufacture of drug products. a. There was no documentation demonstrating that suppliers of components were evaluated and approved by the Quality Unit prior to use. b. For all component suppliers reviewed during the inspection, there was no documentation demonstrating evaluation and approval prior to use. c. No completed supplier questionnaires or audit documentation were available for review. d. There was no documentation establishing defined supplier responsibilities or quality expectations. EMPLOYEE(S) SIGNATURE SEEREVERSE ift to..J ft.s&Q ··· OF THIS PAGE V~ -·· FORM FDA 483 (09/08) PREVIOUS EDITION OBSOLETE EMPLOYEE( S) NAME ANO TITLE (Prin t or Typo) Aer i al A. Smi t h, I n ves ti gator Eri c Bo wl es , I nv est i gat o r INSPECTIONAL OBSERVATIONS DATE ISSUED 0 2/2 7 /2 0 26 PAGE I OF 2 P AG ES -- 1 of 3 -- DIST 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.

Hillyard GMP’s FDA history

Argus HQ has recorded 1 total FDA action tied to Hillyard GMP: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.

Frequently asked questions

Has Hillyard GMP had other FDA inspection citations?: This is the only FDA action Argus HQ has on file for Hillyard GMP so far. Argus ingests new FDA records daily.
What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 3009690111.
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.

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Full FDA history for Hillyard GMP

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). Hillyard GMP — FDA Form 483 Inspection, February 27, 2026 (1 Citations). Digital Empire Holdings LLC. Retrieved from https://argushq.ai/483/hillyard-gmp-3009690111-2026-02-27

MLA

"Hillyard GMP — FDA Form 483 Inspection, February 27, 2026 (1 Citations)." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/483/hillyard-gmp-3009690111-2026-02-27.

Chicago

Argus HQ Research. "Hillyard GMP — FDA Form 483 Inspection, February 27, 2026 (1 Citations)." Digital Empire Holdings LLC. Accessed September 9, 2026. https://argushq.ai/483/hillyard-gmp-3009690111-2026-02-27.

BibTeX

@misc{argushq_argushq_ai_483_hillyard_gmp_3009690111_2026_02_27_2026,
  title = {Hillyard GMP — FDA Form 483 Inspection, February 27, 2026 (1 Citations)},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/483/hillyard-gmp-3009690111-2026-02-27},
  note = {Accessed: September 9, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗