Home / Import refusals / 799-7512285-2/31/1

FDA Import Refusal 799-7512285-2/31/1 — Ascend Laboratories, LLC

Ascend Laboratories, LLC — FEI 3004459274

The FDA refused shipment 799-7512285-2/31/1 from Ascend Laboratories, LLC (United States) on July 8, 2020. The refused product falls under Drugs and Biologics — ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC). Cited charge: 75 This firm has 2 other import refusals on record.

Refusal Details

Date
July 8, 2020
Country
United States
Product Category
Drugs and Biologics
Product Code
61JCA08 ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC)
Charges
75

Recent inspections

  • 1156395 (VAI Wed Nov 10 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1144680 (VAI Thu Jun 24 2021 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1023638 (NAI Thu Jul 06 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 856772 (VAI Wed Dec 11 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 709952 (NAI Thu Feb 10 2011 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

  • Seizure (423707) (Thu May 15 2014 00:00:00 GMT+0000 (Coordinated Universal Time))

Other import refusals

  • 1FX-3323419-6/10002/6 (Tue Jul 07 2026 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9702529-7/81/1 (Wed Sep 29 2021 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources