FDA Form 483s for Alameda Health System IRB, Westwood Labs, Cambrex, Genzyme, and Morgan Gallacher

FDA Form 483s for Alameda Health System IRB, Westwood Labs, Cambrex, Genzyme, and Morgan Gallacher

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Original Request: Please provide the following inspection-related documents in electronic PDF format: The 483 (in electronic format) for the Human Drugs inspection of Alameda Health System IRB, located at 1411 E 31st St, Oakland, CA 94602-1018, United States, inspection ending 10/10/2019 (FEI 3005174856). The 483 (in electronic format) for the Human Drugs inspection of Westwood Laboratories, LLC., located at 710 South Ayon Avenue, Azusa, CA 91702, United States, inspection ending 5/30/2019 (FEI 2020372). The 483 (in electronic format) for the Human Drugs inspection of Avista Pharma Solutions, Inc. dba Cambrex, located at 2620 Trade Centre Ave., Longmont, CO 80503-7551, United States, inspection ending 5/03/2024 (FEI 3012316957). The 483 (in electronic format) for the Human Drugs inspection of Genzyme Corporation, located at 1125 Pleasantview Terrace, Ridgefield, NJ 07657, United States, inspection ending 3/18/2024 (FEI 2246315). The 483 (in electronic format) for the Animal Health and Human Drugs inspection of Morgan Gallacher, located at 8707 Millergrove Dr, Santa Fe Springs, CA 90670, United States, inspection ending 8/23/2019 (FEI 2022194).
Tags: Veterinary, 483, 2019
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.

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