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.

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?

Argus HQ has recorded 2 total FDA actions tied to STAQ Pharma of Ohio LLC. The firm typically has 15 business days to submit a written response describing planned corrections; unresolved or serious findings can lead to a Warning Letter or other enforcement action.

FDA Inspects STAQ Pharma of Ohio LLC: Form 483 with 3 Citations (August 19, 2026)

At a glance: FDA inspected STAQ Pharma of Ohio LLC in Ohio and issued a Form 483 listing 3 inspectional observations following an inspection that concluded 2026-08-19. 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. 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	STAQ Pharma of Ohio LLC
FEI / inspection ID	3025336457
Inspection end date	August 19, 2026
Citation count	3

Citations explained

Observation 1 — Laboratory controls do not include the establishment of scientifically sound and

Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity. Specifically, Your firm's visual inspection qualification procedure for sterile injectable drug products compounded and packaged in syringes is inadequate to ensure that visual inspectors are appropriately qualified to detect defects. A.The visual inspection qualification process does not require operators to distinguish between critical and major defects and the acceptance criteria to pass qualification is (b) {.fl of defective units identi fi ed, regardless of defect severity. For example, the current qualification 4 'Cb><•i for f Hj L_,_ I syringes contains'CbH4 l defects, of which(bH~l are critical defects and ltiH• are major defects. During qualification, operators are not required to document the specific defect type identified, and qualification proctors determine only whether the rejected units contained an actual defect. Thus, operators may fail to identify up to ~l critical defects and still be qualified for

Observation 2 — Batch production and control records do not include in-process results for each batch of

Batch production and control records do not include in-process results for each batch of drug product produced. Specifically, Actual light intensity values measured prior to starting visual inspection are not recorded in the production batch records; instead, the records document only whether the established light intensity acceptance criteria was met using a "Yes/No" check box. For exampl e, for Succinylcholine Chloride 20 mg/mL, 10 mL in 10 mL syringe, Inj ection Batch 62116169A (batch size (6) (4) syringes, manufactured on l (or(4) I, BUD 10/30/2026), light intensity was measured during visual inspection, however, the batch record only documented whether the light intensity met the established acceptance criteria.

Observation 3 — EMPLOYEE(S) SIGNATURE DATE ISSUED SEE REVERSE Li sa R Hilli ar d, I nves ti ga to r

EMPLOYEE(S) SIGNATURE DATE ISSUED SEE REVERSE Li sa R Hilli ar d, I nves ti ga to r 8/19/2 026 OF THIS PAGE Anna M Spiros , Investigator UwRHl lfrd ~~:~ Supreet K Sran , I nv e stigator X UN R. Mili1rd .S ~:,;i~noc1: oa. , g,.2()2o6 P AGE2of4PAGES FORM fl DA 483 (09/08) PREVIOUS EDITION 00S01.E'IB INSPECTIONAL OBSERVATIONS -- 2 of 5 -- DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION OISTRICT ADORESS ANO PHONE NUMBER OATE(S) OF INSPECTION 550 Main Street, Ste 4- 930 8/ 1 0/20 2 6- 8/ 1 9/2026 * Cincinnati, OH 4 5 202 FEI NUMBER 3025336457 (5 1 3)322 - 0700 F ax : (5 1 3)679 - 2772 NAI.E ANO ITTLE OF INDM OUAL TO 11',ttOM REPORT ISSUED Jo seph W. Bagan, CEO FIJlMNAME STREET ADDRESS STAQ Pharma of Ohio, LLC 255 Philli pi Rd CI TY, STATE, ZF CODE, COUl'ITRY TYPE ESTABllSHMEl'IT tlSPECTEO Col u mbus, OH 43228 - 1307 Outsourcing Facility Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process. Specifically, Media fills or aseptic process simulations performed do not closely simulate actual production conditions or represent all syringe configura

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.

STAQ Pharma of Ohio, LLC’s FDA history

Argus HQ has recorded 2 total FDA actions tied to STAQ Pharma of Ohio, LLC: 0 warning letters, 0 recalls, 0 approval records, and 2 Form 483 inspection citations.

Frequently asked questions

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.
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?: Argus HQ has recorded 2 total FDA actions tied to STAQ Pharma of Ohio LLC. The firm typically has 15 business days to submit a written response describing planned corrections; unresolved or serious findings can lead to a Warning Letter or other enforcement action.

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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 (2026). FDA Inspects STAQ Pharma of Ohio LLC: Form 483 with 3 Citations (August 19, 2026). Digital Empire Holdings LLC. Retrieved from https://argushq.ai/483/staq-pharma-of-ohio-3025336457-2026-08-19

MLA

"FDA Inspects STAQ Pharma of Ohio LLC: Form 483 with 3 Citations (August 19, 2026)." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/483/staq-pharma-of-ohio-3025336457-2026-08-19.

Chicago

Argus HQ Research. "FDA Inspects STAQ Pharma of Ohio LLC: Form 483 with 3 Citations (August 19, 2026)." Digital Empire Holdings LLC. Accessed September 23, 2026. https://argushq.ai/483/staq-pharma-of-ohio-3025336457-2026-08-19.

BibTeX

@misc{argushq_argushq_ai_483_staq_pharma_of_ohio_3025336457_2026_08_19_2026,
  title = {FDA Inspects STAQ Pharma of Ohio LLC: Form 483 with 3 Citations (August 19, 2026)},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/483/staq-pharma-of-ohio-3025336457-2026-08-19},
  note = {Accessed: September 23, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗