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 STAQ Pharma of Ohio, 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 STAQ Pharma of Ohio, LLC had other FDA inspection citations?

This is the only FDA action Argus HQ has on file for STAQ Pharma of Ohio, LLC so far. Argus ingests new FDA records daily.

FDA Inspects STAQ Pharma of Ohio, LLC: Form 483 with 1 Citations (May 16, 2025)

Key facts

Firm	STAQ Pharma of Ohio, LLC
FEI / inspection ID	3025336457
Inspection end date	May 16, 2025
Citation count	1

The short version: FDA inspected STAQ Pharma of Ohio, LLC in Ohio and issued a Form 483 listing 1 inspectional observation following an inspection that concluded 2025-05-16. FDA records classify STAQ Pharma of Ohio, 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.

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 thoroughly review the failure of a batch

There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been a lready distributed. Specifically, you did not perfo1m an investigation to identify the root cause(s) for critical defects observed during the 100% visual inspection and the subsequent Accepted Quality Limit (AQL) inspection process. You observed paiiiculate matter that you dete1mine to be critical and major defects during the visual inspection of Dexmedetomidine Hydrochloride 4 mcg/mL, 5mL in a 5mL syringe, Lot [(b (4) I.The initial 100% visual inspection identified 85 defects (74 critical, 9 major and 2 not classified). After this 100% visual inspection, followed by a fail ed AQL inspection which identified 1 critical defect. After you confnmed the AQL failure you did not initiate an investigation to dete1mine the root cause of the critical defect. Instead, you perfo1med a second 100% visual inspection for the same lot. The.

STAQ Pharma of Ohio, LLC’s FDA history

Argus HQ has recorded 1 total FDA action tied to STAQ Pharma of Ohio, LLC: 0 warning letters, 0 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 STAQ Pharma of Ohio, 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 STAQ Pharma of Ohio, LLC had other FDA inspection citations?: This is the only FDA action Argus HQ has on file for STAQ Pharma of Ohio, LLC so far. Argus ingests new FDA records daily.

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Full FDA history for STAQ Pharma of Ohio, 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 (2025). FDA Inspects STAQ Pharma of Ohio, LLC: Form 483 with 1 Citations (May 16, 2025). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-staq-pharma-of-ohio-llc-2025-05-16-3025336457

MLA

"FDA Inspects STAQ Pharma of Ohio, LLC: Form 483 with 1 Citations (May 16, 2025)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-staq-pharma-of-ohio-llc-2025-05-16-3025336457.

Chicago

Argus HQ Research. "FDA Inspects STAQ Pharma of Ohio, LLC: Form 483 with 1 Citations (May 16, 2025)." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-staq-pharma-of-ohio-llc-2025-05-16-3025336457.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_staq_pharma_of_ohio_llc_2025_05_16_3025336457_2025,
  title = {FDA Inspects STAQ Pharma of Ohio, LLC: Form 483 with 1 Citations (May 16, 2025)},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-staq-pharma-of-ohio-llc-2025-05-16-3025336457},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗