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FDA Import Refusal BYA-1000333-3/1/1 — Penn Pharmaceutical Services Limited

Penn Pharmaceutical Services Limited — FEI 1000370240

The FDA refused shipment BYA-1000333-3/1/1 from Penn Pharmaceutical Services Limited (United Kingdom) on August 8, 2016. The refused product falls under Devices — FILLER, BONE VOID, RECOMBINANT PLATELET-DERIVED GROWTH FACTOR. Cited charges: 118,237,3280,341,508 This firm has 5 or more other import refusals on record.

Refusal Details

Date
August 8, 2016
Country
United Kingdom
Product Category
Devices
Product Code
87OYR FILLER, BONE VOID, RECOMBINANT PLATELET-DERIVED GROWTH FACTOR
Charges
118,237,3280,341,508

Recent inspections

  • 1181809 (VAI Fri Apr 01 2022 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1081935 (NAI Fri Feb 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1004548 (NAI Wed Mar 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1063598 (VAI Thu Jan 26 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 979658 (NAI Fri Jul 08 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • 605-8113779-5/21/1 (Mon Aug 20 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-1171120-4/1/1 (Mon Sep 14 2015 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 112-6989379-2/1/1 (Wed Sep 07 2011 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • SG5-0423784-6/1/1 (Tue Dec 08 2009 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • AEK-9915033-2/1/1 (Mon Aug 31 2009 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources