Key facts
| Firm | Nephron Sc Inc |
|---|---|
| FEI / inspection ID | 3010892830 |
| Inspection end date | August 22, 2025 |
| Citation count | 6 |
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 — Procedures designed to prevent microbiologica l contamination of drug products pu rporti
Procedures designed to prevent microbiologica l contamination of drug products pu rporti ng to be steri le are not established and written. 5038 Outsourcing Facility Specifically, A. Your firm failed to perform adequate airflow-visua lization (smoke) studies under dynamic conditions representative of actual aseptic operations. Specifica lly, for example, but not limited to , the fo llowing: a. Laminar Fl ow Hood (LFH) Equipment: Smoke studies for the LFH was not conducted under dynamic conditions representative of actual operations. The studies did not demonstrate unidirectional airf l ow protection of all critical zones during i nte rve nt ions, in cl uding set-up and material manipu lations. b. (l:i )(4) Syringe Fi ller (Room (6)(4), Eq u ipment ID/ NID # [(6) (i:4) I: Airflow visualization (smoke studies) for the (6) (4) syringe fi ller were not performed under dynamic conditions representative of actua l aseptic operations, including i nterventions and operator activities. The current approv ed study did not.
Observation 2 — Aseptic processing areas are deficie nt r ega rding t he system
Aseptic processing areas are deficie nt r ega rding t he system fo r mon ito ring environmenta l conditions. AM ENDMENT 1 EMPI.OYEE(S) SI GNATURE DATE ISSUED SEE REVERSE Sa u ndrea A Munroe, I nves t i ga t or 8/22/2025 OF THIS PAGE Rose L Jean - Mary, I nves t iga t or &u'dle•Alo&,woe Kellia N Hicks, ~8y.8ari:fteAY.n"Oe + I nves t iga t or X .0.8b'ltdC.22--282S Simo ne E Pi t t s, National E xpert -20:21:0S PAGE4ofl4 PAGES F OR\f FDA ~83 (09/ 08) PREVIOUS BDmON OBSOLEJE INS PECTIONAL OBSERVATIO NS
Observation 3 — There is a fai lure t o t ho rough ly review
There is a fai lure t o t ho rough ly review the failure of a batch o r any of it s components t o meet any of its specificatio ns whet her o r not the batch has been already distrib uted . Specifica lly, Sterile Drug Manufacturing & 5038 Out sourcing Facility 1. You have failed to determi ne root cause and impleme nt effect ive correct ive act ion fo r cracked med ia plat es used fo r env ir onment al mo n ito ring (EM ) analysis. You first ident ified t his i ssue on AM ENDMENT 1 EMPI.OYEE(S) SI GNATURE DATE ISSUED SEE REVERSE Sa u ndrea A Munroe, I nves t i ga t or 8/22/2025 OF THIS PAGE Rose L Jean - Mary, I nves t iga t or &u'dle•Alo&,woe Kellia N Hicks, ~8y.8ari:fteAY.n"Oe I nves t iga t or X .0.8b'ltdC.22--282S Simo ne E Pi t t s,.
Observation 4 — Your fi rm failed to establish adequate w rit t en proced
Your fi rm failed to establish adequate w rit t en proced ures fo r production and process co ntrols d es igned to assure t h at the drug products have the ident ity, strength, puri ty , and qualit y that t hey are p urported o r r ep resented to possess. Sterile Drug Manufacturing & 5038 Outsourcing Facility Specifically, 1. Your firm's visual inspect io n metho ds used fo r in halation prod uct s are inadequate. Curr ent ly, th is inspection process fo r visible par ti culates, d iscolorat io n o r tu rbid ity, a crit ica l defect, 4 includes inspect ing 0 [(l5) (~ ) I un its pe(( I> ) ( ) and AQL sa mpli ng at level[(l:5) (4l You r process has not been validated to ensu re you r inspection met hod can adequat ely detect these defects in all prod uct s effecti.
Observation 5 — Aseptic processing areas are defi cie nt r ega rding a ir
Aseptic processing areas are defi cie nt r ega rding a ir supply that is fi lt ere d t hrough high-e ffi ciency part iculate a ir fi lt ers und er positive pr essure. Sterile Drug Manufacturing & 503B Out sourcing Facilit~ Speci fi cally, your fi rm fa iled to fo ll ow pr ocedur es to ensure alarms impacting classified areas are pr ompt ly responded t o, investigat ed, and corrected. Fo r exa mple, duri ng a walkt hr ough of the facility on 11 Aug 2025, we o bse rved tha t t he alarm fo r th e [(6) (4 ) I [(6) (4) I had been alarming for a significa nt amou nt of t ime. The AM ENDMENT 1 EMPI.OYEE(S) SI GNATURE DATE ISSUED SEE REVERSE Sa u ndrea A Munroe, I nves t i ga t or 8/22/2025 OF THIS PAGE Rose L Jean - Mary, I nves t.
Observation 6 — The responsibilit ies and procedures applicable t o t he quality contro
The responsibilit ies and procedures applicable t o t he quality contro l unit are not fu lly followe d. Sterile Drug Manufacturing & 5038 Out sourcing Facility #PC & §9~8 OpeFatieRs SM 08/ 22/ 2025 Specifically, AM ENDMENT 1 EMPI.OYEE(S) SI GNATURE DATE ISSUED SEE REVERSE Sa u ndrea A Mu nroe, I nves ti ga t or OF THIS PAGE Rose L Jean - Mary, I nves t iga t . 8/22/2025 or &u'dle•Alo&,woe Kellia N Hicks, ~8y.8ari:fteAY.n"Oe I nves t iga t or X 0.8b'ltdC.22--282S Simo n e E Pi tt s, Nat ional E xper t - + 20:21:0S F OR\f FDA ~83 (09/ 08) PREVIOUS BDmON OBSOLEJE INS PECTIONAL OBSERVATIO NS PAGE12 of 14 PAGES
Nephron Sc Inc’s FDA history
Argus HQ has recorded 1 total FDA action tied to Nephron Sc 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 Nephron Sc Inc had other FDA inspection citations?
- This is the only FDA action Argus HQ has on file for Nephron Sc Inc so far. Argus ingests new FDA records daily.
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3010892830.
- 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 Nephron Sc 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 Form 483 — Nephron Sc Inc (August 22, 2025) — 6 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-nephron-sc-inc-2025-08-22-3010892830
"FDA Form 483 — Nephron Sc Inc (August 22, 2025) — 6 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-nephron-sc-inc-2025-08-22-3010892830.
Argus HQ Research. "FDA Form 483 — Nephron Sc Inc (August 22, 2025) — 6 Citations." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-nephron-sc-inc-2025-08-22-3010892830.
@misc{argushq_argushq_ai_483_fda_483_nephron_sc_inc_2025_08_22_3010892830_2025,
title = {FDA Form 483 — Nephron Sc Inc (August 22, 2025) — 6 Citations},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-nephron-sc-inc-2025-08-22-3010892830},
note = {Accessed: July 13, 2026}
}