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?

Argus HQ has recorded 3 total FDA actions tied to TAILSTORM HEALTH INC. The firm typically has 15 business days to submit a written response describing planned corrections; unresolved or serious findings can lead to a Warning Letter or other enforcement action.

Has TAILSTORM HEALTH INC had other FDA inspection citations?

Yes. Argus HQ has recorded 3 total FDA actions tied to TAILSTORM HEALTH INC, including 3 Form 483 inspection citations.

What is the FEI / inspection ID for this Form 483?

FEI / inspection ID: 3015929581.

August 28, 2026 FDA Form 483 for TAILSTORM HEALTH INC

FDA inspected TAILSTORM HEALTH INC in Arizona and issued a Form 483 listing 2 inspectional observations following an inspection that concluded 2026-08-28. FDA records classify TAILSTORM HEALTH INC as a outsourcing facility. A Form 483 documents an investigator's findings at the close of an inspection under the Federal Food, Drug, and Cosmetic Act; it is not a final agency compliance determination. The observations on this page are drawn directly from the FDA-issued Form 483 record. 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.

Key facts

Firm	TAILSTORM HEALTH INC
FEI / inspection ID	3015929581
Inspection end date	August 28, 2026
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 3 — Equipment used in the manufactme. processing, packing or holding of drug products is not

Equipment used in the manufactme. processing, packing or holding of drug products is not of approp1~ate design to facilitate operations for its intended use and cleaning and maintenance. Specifically, System e o serve a leaking diaphragm valve after the final (o) (4) ,__..,...... skid used to supply (b) Pfl for all sterile injectable dmgs that contain b) (4 ) Examples of rugs that contain ) (4) from tlus sy stem include: • Ketamine 10% USP. 100 mg/mL, 5 mL , SDV. lot 2602003 • Lidocaine HCl 1%/Epinephrine Bitartrate 10 mc g/mL Injection USP, 10 mL, SDV, lot 2603001 • Albuterol Sulfate 0.5%, 10 mL, lot 2512002 • Bupivacaine Hydrochlo1~de 0.5%/EJ)in lume Bitartrate 5 mcg/mL Injectio 10 mL vial lot 2608001 B. Th ere is an approximately one-foot-long (t:5 4) connected to the (D 4) for the 6 4 on the (bl l4 I System . EMPLOYEE(S) SIGNATURE DATE ISS UED SEE REVERSE Nic ho las L Hu nt, Seni o r cso 08 / 28/2026 OF THIS PAGE Ro nda R Lo yd J o ne s , Inve s ti g at o r Nkholas L l-ull ...... c:so 81gn ed 8y.NkhclfD:::L l-u!t-e X Dlll~ 8 1,gnecl: C8-23-ii! 1121i u :21:115 FORM FDA 483 ( 09 108) PREVIOUS EDmON OB SOll"IE INSP ECTI ONAL OB SE RVATIO NS PAGE 2 of6 PAGES -- 2 of 7 -- DEPARTMENT

Observation 4 — Written records are not always made of investigations into unexplained discrepancies.

Written records are not always made of investigations into unexplained discrepancies. Specifically Particulate Mattei· A. Production processes, procedures, and equipment do not adequately exclude pruticulates and other potential contaminants from sterile inje.ctable and oral inhalation d.!ug product vials. I reviewed the hvo most recent (6J (4 reports for Trending of Vi sible Pati:icle at Visual Inspection. The trend reports include result from 100% visu mspechon ru1d AQL inspection of finished sterile dmg vials. a. PROT.GSP.0025, Visible Particle Trending August-Dec 2025 , approved 02/ 03 /26, documents personnel found visible particulates in multiple vials from a11< •H•1batches manufactured and inspected dming the review period. The number of vials rejected for particulate matter ranged from •• (0.03%) to(l>H• (0.46%) vials in batches that were released. b. PROT.GSP.0035, Visible P a11icle Trending January 2026-Jnne 2026, approved 08/ 18 /26, documents personnel folllld visible pati:iculates in at least one vial from all!bfl• batches manufactured and inspected during the review period. The number of vials rejected for particulate matter ranged from!bl (<0.01 %) to ..11' (0.16%) v

TAILSTORM HEALTH INC’s FDA history

Argus HQ has recorded 3 total FDA actions tied to TAILSTORM HEALTH INC: 0 warning letters, 0 recalls, 0 approval records, and 3 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?: Argus HQ has recorded 3 total FDA actions tied to TAILSTORM HEALTH INC. The firm typically has 15 business days to submit a written response describing planned corrections; unresolved or serious findings can lead to a Warning Letter or other enforcement action.
Has TAILSTORM HEALTH INC had other FDA inspection citations?: Yes. Argus HQ has recorded 3 total FDA actions tied to TAILSTORM HEALTH INC, including 3 Form 483 inspection citations.
What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 3015929581.

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Full FDA history for TAILSTORM HEALTH 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.

APA

Argus HQ Research (2026). August 28, 2026 FDA Form 483 for TAILSTORM HEALTH INC — 2 Citations. Digital Empire Holdings LLC. Retrieved from https://argushq.ai/483/tailstorm-health-3015929581-2026-08-28

MLA

"August 28, 2026 FDA Form 483 for TAILSTORM HEALTH INC — 2 Citations." Argus HQ Research, Digital Empire Holdings LLC, 2026, argushq.ai/483/tailstorm-health-3015929581-2026-08-28.

Chicago

Argus HQ Research. "August 28, 2026 FDA Form 483 for TAILSTORM HEALTH INC — 2 Citations." Digital Empire Holdings LLC. Accessed October 12, 2026. https://argushq.ai/483/tailstorm-health-3015929581-2026-08-28.

BibTeX

@misc{argushq_argushq_ai_483_tailstorm_health_3015929581_2026_08_28_2026,
  title = {August 28, 2026 FDA Form 483 for TAILSTORM HEALTH INC — 2 Citations},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire Holdings LLC},
  url = {https://argushq.ai/483/tailstorm-health-3015929581-2026-08-28},
  note = {Accessed: October 12, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗