Key facts
| Firm | Olympia Pharmaceuticals |
|---|---|
| FEI / inspection ID | 3009724085 |
| Inspection end date | August 8, 2025 |
| Citation count | 3 |
Citations explained
Observation 1 — Procedures designed to prevent microbiological contamination of mug products pmp o1ting to
Procedures designed to prevent microbiological contamination of mug products pmp o1ting to be sterile did not inclu de adequate validation of the aseptic process. Specifically, A. During the observation of air visualization study SO# FL-OYPP232701P-1 fo r your dynamic aseptic filling operation in Buffer Roo~, Unit ID: K15) rrt the fo llowing deficiencies were noted: 1. The setup of vials, stoppers, and caps at the edge of the hood results in air arching and <lI·agg ing, which prevents these critical components from receiving first air. 2. The filler needle isKo) (4) Ioriented within a[(t:>) (4~ laminar flow hood blocking unidirectional airflow. 3 . The viable air monitor's functionality was n ot demonstrated during operation, therefore, there is no evi de nce to show that its placement could a ffect airflow in the critical area. B. Dynamic FPC50 air visualization study: 1. Air visualization studies show air arching over stoppers, caps, and seals, indicating that these critical components are n ot.
Observation 2 — Your fnm failed to establish adequate written procedures for production and process
Your fnm failed to establish adequate written procedures for production and process controls designed to assure that the diug products have the identity, strength, purity, and quality that they are purported or represented to possess. Specifically, A. Your fnm lacks assurance that the light conditions are adequate for the visual inspection of amber-colored vials. Specifically: 1. Your procedure, SOP-007 "Visual Inspection of Sterile Drng Products" (version 13 , effective 07/ 03 /2025), requi1ts li~t intensity to be measured and documented [(o ) (~.LJ use, with a specifi ed range o (6ff4 to 6>14 Lux. This range is not justified as bemg adequate for the effective inspection of amber vial s. 2. Fmthe1more, while your fnm claims t~at li ~t levels at the working height are consistently within an acceptable range of(b) (4 to (o) (4) Lux, your cmTent procedures and documentation do not require or de monstrate the measurement of light intensity at the actual working height of the inspection.
Observation 3 — Aseptic processing areas are de fi cient regarding the system fo r
Aseptic processing areas are de fi cient regarding the system fo r cleaning and disinfecting the to produce aseptic conditions. Speci fi cally, A. During the [(b) (4) I cleaning and disinfection of the ISO 5 Laminar Airfl ow Workstations (LAFWs) and Auto Filler Systems (AF) in Cleam oom 305 on 8/5/2025, I observed three cleaning operators exhibiting poor cleaning practices. S~ecifically, after the interior surfaces of the LAFWs (LAFW ~D) (4 t LAFW~D) (~J and L AFwrt> ) (4J.) had been disinfect ed, I observed the cleaning operators stepping insi.cle tlie LAFWs ai·ea ana making contact with the cleaned inte rior walls of the LAFWs by leaning against them with their gaim ents (backs, shoulders, or aims) while cleaning the auto-filler units. B. Additionally, when the operator was cleaning the exterior walls of the LAFW 4 H I observed the operator 's gloved hand contact the previously disinfect ed LAFW 41 ff interior wall. This contact occuned when the.
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.
Olympia Pharmaceuticals’s FDA history
Argus HQ has recorded 1 total FDA action tied to Olympia Pharmaceuticals: 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 Olympia Pharmaceuticals had other FDA inspection citations?
- This is the only FDA action Argus HQ has on file for Olympia Pharmaceuticals so far. Argus ingests new FDA records daily.
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3009724085.
- 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.
See if this 483 escalates to a warning letter — before your auditor asks.
Free weekly briefing tracks every FDA inspection outcome.
Related enforcement actions
Full FDA history for Olympia PharmaceuticalsCompiled 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 Olympia Pharmaceuticals: Form 483 with 3 Citations (August 8, 2025). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-olympia-pharmaceuticals-2025-08-08-3009724085
"FDA Inspects Olympia Pharmaceuticals: Form 483 with 3 Citations (August 8, 2025)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-olympia-pharmaceuticals-2025-08-08-3009724085.
Argus HQ Research. "FDA Inspects Olympia Pharmaceuticals: Form 483 with 3 Citations (August 8, 2025)." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-olympia-pharmaceuticals-2025-08-08-3009724085.
@misc{argushq_argushq_ai_483_fda_483_olympia_pharmaceuticals_2025_08_08_3009724085_2025,
title = {FDA Inspects Olympia Pharmaceuticals: Form 483 with 3 Citations (August 8, 2025)},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-olympia-pharmaceuticals-2025-08-08-3009724085},
note = {Accessed: July 13, 2026}
}