Key facts
| Firm | TAILSTORM HEALTH INC |
|---|---|
| FEI / inspection ID | 3022483154 |
| Inspection end date | November 14, 2025 |
| Citation count | 3 |
Citations explained
Observation 1 — Established laborato1y control mechanisms are not fo llowed
Established laborato1y control mechanisms are not fo llowed. Speci fi cally, Your fnm does not have an establish ed system suitability procedure. Your fnm per fo1ms the Light Obscuration Paiiicle Co unt Test using your [(15) (.2J) I Paiiicle Count {jPC) fo r finish ed dmg product release testing. However, your fnm has not conducted method suitability testing fo r bevacizumab (Avastin) sterile intravitreal pre-filled syringes. Your fnm utilizes the (( b ) (4) ITechnique to test fo r paiiiculate matter fo r sterile intravitreal injectables, including bevacizum ab (Avastin) pre-filled syringes, lot D 25 110 (BUD: l 7/SEP/2026).
Observation 2 — Laborato1y records ai·e de fi cient in that they do not include
Laborato1y records ai·e de fi cient in that they do not include a complete record of all data obtained during testing. Speci fi cally, Your fnm does not have an established procedure fo r the review of audit trails to ens ure the reliability of EMPLOYE E($) SIGNATURE DATE lSSUEO SEE REVERSE Cecilia H Kieu, Investigator 11 / OF THIS PAGE Cec:lla H l(Ja, ceoaa H.. Kieu-s X = 1 4/2025 ~ : 11•14-202S 11 '
Observation 3 — Buildings used in the manufact ure, processing, packing or holding of dmg
Buildings used in the manufact ure, processing, packing or holding of dmg products are not maintained in a clean and sanitaiy condition. Speci fi cally, On 11 /11/2025, during the fi lling of bevacizumab (Avastin), lot D25120, I observed an uni de nti fi ed white string on the ceiling of the ISO~( fi lling room. The condition of the ceiling surface presents a potential source of pa1ticulate containination within the classi fi ed ar ea used fo r aseptic processing. *DATES OF INSPECTION 11 / 03 /2025(Mon), 11 /04/2025(Tu e) , 11 / 05 /2025(Wed), 11/06/2025(Thu), 11/07 /2025(Fri), 11 /1 0/2025(Mon), 11 /11/2025(Tue), 11 /1 2/2025(Wed), 11/ 13 /2025(Thu), 11/14/2025(Fri) SEE REVERSE OF THIS PAGE EMPLOYE E($) SIGNATURE Cec i l ia H Kie u , I n ve s ti g at o r DATE lSSUEO 11 / 1 4/202 5
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.
TAILSTORM HEALTH INC’s FDA history
Argus HQ has recorded 2 total FDA actions tied to TAILSTORM HEALTH INC: 0 warning letters, 0 recalls, 0 approval records, and 2 Form 483 inspection citations.
Frequently asked questions
- Does this Form 483 mean TAILSTORM HEALTH 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 TAILSTORM HEALTH INC had other FDA inspection citations?
- Yes. Argus HQ has recorded 2 total FDA actions tied to TAILSTORM HEALTH INC, including 2 Form 483 inspection citations.
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3022483154.
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Related enforcement actions
Full FDA history for TAILSTORM HEALTH 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). TAILSTORM HEALTH INC — FDA Form 483 Inspection, November 14, 2025 (3 Citations). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-tailstorm-health-inc-2025-11-14-3022483154
"TAILSTORM HEALTH INC — FDA Form 483 Inspection, November 14, 2025 (3 Citations)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-tailstorm-health-inc-2025-11-14-3022483154.
Argus HQ Research. "TAILSTORM HEALTH INC — FDA Form 483 Inspection, November 14, 2025 (3 Citations)." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-tailstorm-health-inc-2025-11-14-3022483154.
@misc{argushq_argushq_ai_483_fda_483_tailstorm_health_inc_2025_11_14_3022483154_2025,
title = {TAILSTORM HEALTH INC — FDA Form 483 Inspection, November 14, 2025 (3 Citations)},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-tailstorm-health-inc-2025-11-14-3022483154},
note = {Accessed: July 15, 2026}
}