Key facts
| Firm | TAILSTORM HEALTH INC |
|---|---|
| FEI / inspection ID | 3015929581 |
| Inspection end date | May 23, 2025 |
| Citation count | 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.
Citations explained
Observation 1 — The separate or defined areas and control systems necessary to prevent contamination
The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient. Specifically, your firm's batch records document significant environmental monitoring excursions during filling of sterile drugs. A) Nonviable particulate counter (NVPC) data for five of six lots we reviewed of the total Jots that were manufactured in 2025 using the new ISO 5 filling line indicate numerous action limit results occurred during filling, but your quality unit did not document a thorough investigation. For example, the following five batches were released and the first four listed were distributed: • Bupivacaine HCI 0.5%/Epinephrine Bitartrate 5 mcg/mL Injection, 10 mL, lot had approximately 73 action limit results for particles and approximately 104 action limit results for particles. The maximum result fora;a1a,;-..__, was 39,258 particles/m 3 and the maximum result for .aia.;;..., was 1,237 particles/m 3 . • Ketarnine 1% 10 mg/mL, 5 mL (SDV), Jot had approximately 1 action limit re;s;;;;u;.;lt.;.£;or.,..,--.-::-! and approximately 3 action limit results.
Observation 2 — 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. (This is a repeat observation.) Specifically, OOS investigations did not always contain complete written justification to support the root cause and conclusions, and investigations were not always expanded to additional lots when implicated by the root cause. A) Investigations OOS.23.015 (lot.11;a;_ __, 00S.24.001 (lot __ __, and OOS.23.016 (lot'.--"-' identified sample handling and preparation at your contract laboratory as the probable root cause for OOS liquid particle count results in finished drug lots but did not include specific actions by analysts that might have caused the OOS. The contract laboratory investigation did not find any laboratory errors. There was no thorough explanation of the discrepancy between your investigation and your contract laboratory's investigation. There was no record ofremedial action at your contract laboratory to.
Observation 3 — Acceptance criteria for the sampling and testing conducted by the quality control
Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to a~sure that batches of drug products meet each appropriate specification and appropriate statistical quality control criteria as a condition for their approval and release. (This is a repea t o bs ervation.) Specifically, we observed multiple deficiencies when we examined your firm's visual inspection, AQL, and particle identification procedures, processes, and executed records. A) Your firm did not determine the identity, source, and route of contamination for particles and fibers observed inside sterile finished drug vials during 100% visual inspection and AQL performed.::;:iiu,.:.,__...,.._,,.___ __, for Jots we examined. The Jots met acceptance criteria for VI and AQL and were released with no additional investigation. For example, • Inspectors identified 83 units with particles and 16 units with fibers during 100% visual inspection of Sterile Water for Injection, USP 10 mL, Jot._._...... • Inspectors identified 21 units with particles and eight units with fibers.
Observation 4 — Routine inspection and checking of equipment is not performed according to a
Routine inspection and checking of equipment is not performed according to a written program designed to assure proper performance. Specifically, we observed the (b) (4) unit on your (b) (4) leaking and creating a puddle on the floor on 05/ 14/25. There were no records available to determine how long this leak was present. Your firm uses to produce approximately different -.a.a:....---"" injectable drugs. Examples of lots produced with include: Sterile Water for Injection, USP 10 mL, Jot -,;a~.,_. Bupivacaine HCl 0.5%/Epinephrine Bitartrate 5 mcg/mL Injection, 10 mL, lot,o:;:aca.:ao....., Ketamine 10% 100 mg/mL, 5 mL (MDV), lot-.aai..., and Bupivacaine HCI Injection USP 0.25%, 10 mL, lot.11a.-.ai...1
Observation 5 — Buildings used in the manufacturing, processing and packing of a drug product
Buildings used in the manufacturing, processing and packing of a drug product are not maintained in a good state of repair. Specifically, we observed maintenance deficiencies with the cleanrooms production technicians use to manufacture all 11:aui.;a..____.., injectable drugs including: Sterile Water for Injection, USP 10 mL, Jot Bupivacaine HCI 0.5%/Epinephrine Bitartrate 5 mcg/mL Injection, 10 mL, Jot 11a.-.al...f Ketamine 10% 100 mg/mL, 5 mL (MDV), lot _.aai..., and Bupivacaine HCl Injection USP 0.25%, 10 m L, lot11a.-.ai...1 A) We observed multiple pieces of apparent tape under the conveyor belt and on the wall surrounding the outlet from the sealing and capping station of the ISO 5 filling line into the ISO 7...,u,.:;._.., room. There was no written explanation of why the tape was present or how long it was present. B) We observed a missing electrical outlet cover in the ISO 7a;ay,,,;.__, room with an apparent black substance surrounding the entire outlet. There was no written explanation of how long.
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
- Where can I read the full Form 483?
- The verbatim inspection record is the source of truth — always confirm citation language against the original FDA document before acting.
- What is an FDA Form 483?
- A Form FDA 483 lists an FDA investigator's written observations at the close of a facility inspection, issued under section 704(b) of the Federal Food, Drug, and Cosmetic Act. It documents conditions the investigator judged may violate FDA regulations. A 483 is not an enforcement action or a final determination that a violation occurred.
- 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.
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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). Form 483 Record: TAILSTORM HEALTH INC, May 23, 2025 — 5 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-tailstorm-health-inc-2025-05-23-3015929581
"Form 483 Record: TAILSTORM HEALTH INC, May 23, 2025 — 5 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-tailstorm-health-inc-2025-05-23-3015929581.
Argus HQ Research. "Form 483 Record: TAILSTORM HEALTH INC, May 23, 2025 — 5 Citations." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-tailstorm-health-inc-2025-05-23-3015929581.
@misc{argushq_argushq_ai_483_fda_483_tailstorm_health_inc_2025_05_23_3015929581_2025,
title = {Form 483 Record: TAILSTORM HEALTH INC, May 23, 2025 — 5 Citations},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-tailstorm-health-inc-2025-05-23-3015929581},
note = {Accessed: July 15, 2026}
}