Key facts
| Firm | UBI Pharma Inc. |
|---|---|
| FEI / inspection ID | 3004713402 |
| Inspection end date | October 14, 2025 |
| Citation count | 4 |
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 — Equipment used in the manufacture, processing, packing or holding of diu g
Equipment used in the manufacture, processing, packing or holding of diu g products is not of appropriate design to facilitate operati ons fo r its inte nded use. t· (6)(4) Specifically, the visual inspection of your In~ ' ec 10n mL (6) (4) vials is caITi ed out in (b)(4) The resulting vials then undergo Acceptance Quality Limit (AQL) testing before releasing. You cany out AQL testing via (6)<4> R • f h 1·fi • f (6)<4> e VI ew o t e qua 1 cat10n report o your (b)(4) ....,..-~---,---,------ P QR/GT 2.3 .11 8.03 Version 01 E ffecti ve date 11 / 10/2018 confiimed th at the tOH 41 .,.._wa_s_n_o_t_q_u_a_li_fi-ed fo r the defect categories fo r (6H4> Injection mcg/mL~~mL an d~~ mL vials. The qualification is based on limited number of samples that '(6) tbl(4) (6)(6) include k4> de fect samples and random samples. Your Production Manager could not produce a list of these vials nor was.
Observation 2 — Control procedures are not established w hich monitor the output and validate
Control procedures are not established w hich monitor the output and validate the perfo1mance of those manufachlring processes that m ay be responsible for causing variab ility in the characteristics of in process m aterial and the diug product. Specifically, your procedures SOP No. P31 90 Version 07, Operating, Cleaning, a nd Maintenance Procedure of (6H4 > Effective date 1/ 8/2024), SOP No. P3109 Version 15 Sterile CbH4 > Liquid Vial Inspection Procedure (Effective date 12/9/2024), a nd SOP No. P801 Version 5 Sampling Plan and AQL Calculation (Effective date 3/ 10/2 025) fail to ensure your sterile (b)(4) products are essentially free of visible particulates s uch that; EMPLO YEE ($) SIGNATURE EMPLOYEE(S) NAME AND TITLE (Printor Type) DATE I SSLE0 10/1 4/2025 RAJ IV R. Digita lly signed by SEE REVERSE OF SRIVASTAVA _RAJIVR.SR IVASTAVA-S Date:2025.10.14 Rajiv R Srivastava, cso S 13:43:44 +08'00' THIS PAGE FORM FDA -l&l (09/08) PREVIOUS EDmON OBSOLETE INSPECTIONAL OBSERVA TIONS PAGE20F9PAGES
Observation 3 — Procedures designed to prevent microbiological contamination of diug products purpo1iing to be
Procedures designed to prevent microbiological contamination of diug products purpo1iing to be sterile are not established and/or fo llowed. Specifically, Protocol PQ/GT2.3.224 Version 01 Perfo1mance Qualification Protocol of Laminar Flow (li) (4) . (li) (4) (li) (4) . Hood for __________ Machme _____ ID# ___ Effective date 4/ 18/2023 and the Version 02 (Effective date 4/ 12/2024) provide procedure for perfo1ming and evaluating the air (li)(4> L . (b) • R (b)(4> hi gh k di F 1 .d d d f h fl ow of ______ me <4> m oom t ·ou smo e stu es. or examp e, v1 eo recor e o t e • fl d. £ d Cb><4> d(b><4> d fi • • h £ 11 • au ow stu 1es per 01me ___ an were e c1ent m t e o owmg ways. (li)(4) A. In multiple intervention simulation studies, the purpose of the smoke study was not (bH4> • • • 1 •.
Observation 4 — There is a failure to thoroughly review any unexplained discrepancy and the
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. .fi 11 £ (li)(4) • • • (li)(4) g/mL (Ii) mL • (Ii) mL • 1 (li) (4) Speci ica y, youmanu acture _______ mJect10n me <4> m c4> via as 4 diug product. You received at least 15 market complaints for paitially filled vials, empty""v_i_a-ls-, ...and crack/leak vial (Table 1). You investigated only 3 (three) of these market complaints; (bH 4 > (Batch No. (bH4> Expiiy date (bH4> (Batch No. (bH4> Mfg. date 11 / 1/2023 Expiiy 41 4 4 date \OJ\ (Batch No. Cb>< > Mfg. date 12/3/2023 Expiiy date (bH > Section 5.1.2 of SOP No. P818 Version 08 Handling of Product Complaints (Effective date 12/ 13/2024) requires, "QA supervisor should acquire the complaint sample(s) from the customer to facilitate the.
UBI Pharma Inc.’s FDA history
Argus HQ has recorded 1 total FDA action tied to UBI Pharma Inc.: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.
Frequently asked questions
- Does this Form 483 mean UBI Pharma Inc. 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 UBI Pharma Inc. had other FDA inspection citations?
- This is the only FDA action Argus HQ has on file for UBI Pharma Inc. so far. Argus ingests new FDA records daily.
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3004713402.
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Related enforcement actions
Full FDA history for UBI Pharma Inc.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.
Argus HQ Research (2025). FDA Inspects UBI Pharma Inc.: Form 483 with 4 Citations (October 14, 2025). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-ubi-pharma-inc-2025-10-14-3004713402
"FDA Inspects UBI Pharma Inc.: Form 483 with 4 Citations (October 14, 2025)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-ubi-pharma-inc-2025-10-14-3004713402.
Argus HQ Research. "FDA Inspects UBI Pharma Inc.: Form 483 with 4 Citations (October 14, 2025)." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-ubi-pharma-inc-2025-10-14-3004713402.
@misc{argushq_argushq_ai_483_fda_483_ubi_pharma_inc_2025_10_14_3004713402_2025,
title = {FDA Inspects UBI Pharma Inc.: Form 483 with 4 Citations (October 14, 2025)},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-ubi-pharma-inc-2025-10-14-3004713402},
note = {Accessed: July 15, 2026}
}