Home / Import refusals / 97Y-0197302-1/11/1

FDA Import Refusal 97Y-0197302-1/11/1 — Patcos Cosmetics (India) Private Limited

Patcos Cosmetics (India) Private Limited — FEI 3009250196

The FDA refused shipment 97Y-0197302-1/11/1 from Patcos Cosmetics (India) Private Limited (India) on April 15, 2024. The refused product falls under Drugs and Biologics — SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC). Cited charge: 27 This firm has 5 or more other import refusals on record.

Refusal Details

Date
April 15, 2024
Country
India
Product Category
Drugs and Biologics
Product Code
63RAJ04 SODIUM FLUORIDE (DENTAL CARIES PROPHYLACTIC)
Charges
27

Recent inspections

  • 1279747 (OAI Fri Jul 18 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1200616 (VAI Fri Mar 24 2023 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1025819 (VAI Wed Sep 20 2017 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 97Y-0197294-0/11/1 (Mon Apr 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 97Y-0197294-0/21/1 (Mon Apr 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 97Y-0197294-0/41/1 (Mon Apr 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 97Y-0197294-0/51/1 (Mon Apr 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 97Y-0197294-0/31/1 (Mon Apr 15 2024 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources