Facility

Tampon Innovations

1 recall(s) on record — most severe on record: Class II.

Key facts

1recalls · worst Class II

1inspections · worst OAI

1warning letters

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3028725772
Establishment type	Complaint File Establishment per 21 CFR 820.198; Repack or Relabel Medical Device; Manufacture Medical Device
Location	41A Rozhen Blvd Sofia Sofia-Grad, BG 1271
Registration status	Active · expires 2026
Parent company	Daye (Anne's Day Ltd) (owner-operator 10088636)
Brand names	Daye Vaginal Tampon Swab; Daye at-Home Microbiome Screening; Daye at-Home Vaginal Microbiome Screen; Vaginal Microbiome Test

Activity by year

Recalls (1)
Inspections (1)
Warning letters (1)

Devices registered here (1)

Applicator, Absorbent Tipped, Non-Sterile
Product code KXF (opens in a new tab) · Class I · General Hospital · 21 CFR 880.6025

Recalls & enforcement

Class IIOngoing2025-02-17
Product lacks 510(k) clearance.

FDA inspections (1)

OAI2024-07-11
Official Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

Warning Letter2024-12-17
Warning Letter (opens in a new tab) · Iliyantsi

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Tampon Innovations (FEI 3028725772) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3028725772-tampon-innovations/

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