Does this Form 483 mean OurPharma 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 OurPharma LLC had other FDA inspection citations?

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

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

FEI / inspection ID: 3014064135.

August 12, 2026 FDA Form 483 for OurPharma LLC

FDA inspected OurPharma LLC in Arkansas and issued a Form 483 listing 2 inspectional observations following an inspection that concluded 2026-08-12. FDA records classify OurPharma 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	OurPharma LLC
FEI / inspection ID	3014064135
Inspection end date	August 12, 2026
Citation count	2

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 2 — Records are not maintained so that data therein can be reviewed at least annually to

Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each diug product to dete1mine the need for changes in specifi cations or manufacturing or control procedures. Specifically, Annual product review (APR) records fo r six di11 g product families - Fentanyl Citrate, Fentanyl Citrate + Bupivacaine HCl, Fentanyl Citrate + Ropivacaine HCl, Hydi·omorphone HCl, Morphine HCl, and Ropivacaine HCl, covering review period 202 4-20 25 - contain multiple numeri ca l inconsistencies, EMPLOYEE(S) SI GNATURE DATE ISSUED SEE REVERSE Bea t rix D Hippe, I nves t iga t o r 8/12/2026 OF THIS PAGE &e 110H1»e striecf8y. ~--1 ,r• 8EATRIXO ,2-~ . HPFE ◄ X INS PEC TIONAL OB SERVATIONS PAGE 2 of? FORM FDA ~83 ( 09/ 08) PAGES PREVIOUS EDmON OBSOLEJE -- 2 of 8 -- DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION DISTRICT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPECTION 1201 Main S treet, Sui te 7200 8/3/2026 - 8/ 1 2/2026* Dallas, TX 75202 FEJNUMBER 301 406 4135(214 )253 - 5200 Fax: (214 )253 - 5314 NAME AND TITLE OF INDIVIDUAL TO WHOM REPORT ISSUED Adam S Kohler, Chief Executive Officer F IRM NAME STREET ADDRESS OurPharma LLC

Observation 3 — Dmg product production and control records, are n ot reviewed by the quality control unit

Dmg product production and control records, are n ot reviewed by the quality control unit to dete1mine compliance with all establish ed, approved written procedures before a batch is released or distributed. EMPLOYEE(S) SI GNATURE DATE ISSUED SEE REVERSE Bea t rix D Hippe, I nves t iga t or 8/ 2/2026 OF THIS PAGE &e-1110H1»e ~striecf8y. - 1 ,r• 8EATRIXO ,2-~. HPFE ◄ X PAGE FORM FDA ~83 (09/ 08) C of? PAGES PREVIOUS EDmON OBSOLEJE INS PE TIONAL OB SERVATIONS 5 -- 5 of 8 -- DEPARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMINISTRATION D I STRI CT ADDRESS ANO PHONE NUMBER OATE(S) OF INSPEC TION 1 20 1 Main Street, Suite 7 200 8 / 3 /202 6 - 8 / 1 2/202 6* Dallas, TX 75 202 FEJNUMBER 3 0 14 0 64135 (2 14) 2 53 - 5 200 Fax: (2 14) 2 53 - 5314 NAME AND TITLE OF I NDIVI DUAL TO WHOM REPORT ISSUED Adam S Ko hler, Chief Executive Officer F IRM NAME STREET ADDRESS OurPharma LLC 2 51 2 S City Lake Rd C ITY . STATE. ZIP CODE. COUITTRY TYPE ESTABU SHME NT INSPECTED Fayetteville, AR 7 2 7 01 - 5 0 13 Outs o urcing Facility Specifica lly, Your Out of Specification (OOS) procedure, GMP- SO P-0047 (Out of Specification (OOS) SOP), does not establish defined timeframes fo r the completion of

OurPharma LLC’s FDA history

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

Frequently asked questions

Does this Form 483 mean OurPharma 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 OurPharma LLC had other FDA inspection citations?: This is the only FDA action Argus HQ has on file for OurPharma LLC so far. Argus ingests new FDA records daily.
What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 3014064135.

See if this 483 escalates to a warning letter — before your auditor asks.

Free weekly briefing tracks every FDA inspection outcome.

Full FDA history for OurPharma 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). August 12, 2026 FDA Form 483 for OurPharma LLC — 2 Citations. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/483/ourpharma-3014064135-2026-08-12

MLA

"August 12, 2026 FDA Form 483 for OurPharma LLC — 2 Citations." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/483/ourpharma-3014064135-2026-08-12.

Chicago

Argus HQ Research. "August 12, 2026 FDA Form 483 for OurPharma LLC — 2 Citations." Digital Empire Holdings LLC. Accessed September 23, 2026. https://argushq.ai/483/ourpharma-3014064135-2026-08-12.

BibTeX

@misc{argushq_argushq_ai_483_ourpharma_3014064135_2026_08_12_2026,
  title = {August 12, 2026 FDA Form 483 for OurPharma LLC — 2 Citations},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/483/ourpharma-3014064135-2026-08-12},
  note = {Accessed: September 23, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗