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FDA Import Refusal BMB-0017166-8/11/1 — Divi's Laboratories Ltd. (Unit II)

Divi's Laboratories Ltd. (Unit II) — FEI 3004149463

The FDA refused shipment BMB-0017166-8/11/1 from Divi's Laboratories Ltd. (Unit II) (India) on April 10, 2017. The refused product falls under Drugs and Biologics — PHENYLEPHRINE HCL (ADRENERGIC). Cited charges: 27,3600,3845 This firm has 3 other import refusals on record.

Refusal Details

Date
April 10, 2017
Country
India
Product Category
Drugs and Biologics
Product Code
60CAS09 PHENYLEPHRINE HCL (ADRENERGIC)
Charges
27,3600,3845

Recent inspections

  • 1244994 (VAI Fri Jul 19 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1121124 (NAI Fri Jan 31 2020 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1029997 (VAI Tue Sep 19 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 996506 (OAI Tue Dec 06 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 960638 (NAI Fri Feb 19 2016 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Other import refusals

  • SCS-2626386-5/11/1 (Tue Dec 29 2020 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 334-2782350-6/11/1 (Wed Apr 26 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)
  • 110-9373369-9/1/1 (Fri Sep 01 2006 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources