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ASPEN SA STERILE OPERATIONS (PTY) LTD — FDA Facility Profile

FEI 3007490529

ASPEN SA STERILE OPERATIONS (PTY) LTD is an FDA-registered facility (FEI 3007490529) located in South Africa (ZAF). Registered operations: ANALYSIS; LABEL; MANUFACTURE; PACK; STERILIZE. RegDataLab tracks 5 FDA inspections and 1 compliance action at this facility.

Facility Details

Location
South Africa (ZAF)
Registration Expires
December 31, 2026
Operations
ANALYSIS; LABEL; MANUFACTURE; PACK; STERILIZE
Source
decrs

Recent inspections

  • 1249416 (OAI Tue Sep 17 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1074310 (VAI Tue Dec 04 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 969055 (VAI Tue Apr 19 2016 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 882533 (NAI Fri May 23 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 786162 (NAI Thu May 17 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Compliance actions

Import refusals

  • T77-1541592-5/11/1 (Tue Aug 27 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Devices)

FDA data resources