Key facts
| Firm | Delta Pharma Inc |
|---|---|
| FEI / inspection ID | 3004034796 |
| Inspection end date | November 21, 2025 |
| 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 1 — The labels of your outsourcing facility's drng products do not include info1mation
The labels of your outsourcing facility's drng products do not include info1mation required by section 503B(a)( l0) (A) of the Federal Food, Drng, and Cosmetic Act (FD &C Act). Specifically, the semaglutide finished product primaiy labels fo r batches 05-0325-001, 05-0425-001, 05- 0525- 001 , 05-0525-002, and 05 -0525-003, do not include the fo llowing info1mation: Address of your fom , and the statements "NOT F OR RESALE" and "OFFICE USE ONLY". Material System
Observation 2 — Approved components are not retested or reexamined as appropriate fo r identity
Approved components are not retested or reexamined as appropriate fo r identity, strength, quality and purity after storage fo r long periods with subsequent approval or rejection by the quality control uni t. Specifically, the raw material, Sterile water for Injection, USP, lot (6) 02], expiration date 31Mai·ch2025, was used in the production of the fi nished product, Semaglutide 2.5mg/mL, product batch 02-0225- 001 , expiration date 02 April 2025. The lot produced 4 t6f( l vials which were distributed for commercial use. *DATES OF INSPECTION l l /10/2025(Mon), l l /12/2025(Wed), l l/ 13 /2025(Thu), l l/ 14/2025(Fri), 11 /17/2025(Mon), l l /21/2025(Fri) EMPLOY EE($) SIGNATURE DATE lSSUEO SEE REVERSE Jared P Stevens, Investigat o r OF THIS PAGE -- 11 /2 1 /2025 .tftdP8aie¥enl ~8y. JMEO P. 8TEVEN8· X Clele:~ 1H 1·:m5 ''''""
Delta Pharma Inc’s FDA history
Argus HQ has recorded 1 total FDA action tied to Delta Pharma Inc: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.
Frequently asked questions
- 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 Delta Pharma Inc had other FDA inspection citations?
- This is the only FDA action Argus HQ has on file for Delta Pharma Inc so far. Argus ingests new FDA records daily.
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3004034796.
- 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.
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Related enforcement actions
Full FDA history for Delta Pharma IncCompiled 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.
Argus HQ Research (2025). FDA Inspects Delta Pharma Inc: Form 483 with 2 Citations (November 21, 2025). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-delta-pharma-inc-2025-11-21-3004034796
"FDA Inspects Delta Pharma Inc: Form 483 with 2 Citations (November 21, 2025)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-delta-pharma-inc-2025-11-21-3004034796.
Argus HQ Research. "FDA Inspects Delta Pharma Inc: Form 483 with 2 Citations (November 21, 2025)." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-delta-pharma-inc-2025-11-21-3004034796.
@misc{argushq_argushq_ai_483_fda_483_delta_pharma_inc_2025_11_21_3004034796_2025,
title = {FDA Inspects Delta Pharma Inc: Form 483 with 2 Citations (November 21, 2025)},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-delta-pharma-inc-2025-11-21-3004034796},
note = {Accessed: July 13, 2026}
}