FDA Investigator Andrew Le

Andrew Le has conducted inspections on 12 sites in 2 countries as of 02 Apr 2024. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
12
Last Inspection Date:
02 Apr 2024
Investigator Role:
FDA Investigator
Redica ID:
Countries of Inspections:
United States of America, India

Andrew Le's Documents

Publish Date Document Type Title
April, 2024 FDA 483 Dr. Brite LLC - Form 483, 2024-04-05
November, 2023 FDA 483 Wedgewood Connect, LLC - Form 483, 2023-11-17
December, 2022 FDA 483 Mr. Lulu LLC - Form 483, 2022-12-09
July, 2023 FDA 483 Sun Pharmaceutical Medicare Limited - Form 483, 2023-07-13
July, 2023 FDA 483 Aurobindo Pharma Limited - Form 483, 2023-07-21
November, 2022 FDA 483 Yusef Manufacturing Laboratories, LLC - Form 483, 2022-11-04
June, 2022 EIR PETNET SOLUTIONS, INC. - EIR, 2022-06-15
August, 2022 FDA 483 Clean Cosmetics, LLC - Form 483, 2022-08-19
February, 2023 FDA 483 ACTA Laboratories Inc - Form 483, 2023-02-13
February, 2024 FDA 483 PUREMEDY - Form 483, 2024-02-12
July, 2022 FDA 483 Kari Gran Inc. - Form 483, 2022-07-08
September, 2023 FDA 483 Orange Lab - Form 483, 2023-10-25
May, 2024 FDA 483 Polypeptide Laboratories, Inc. - Form 483, 2024-05-10
September, 2024 FDA 483 Wasatch Product Development, LLC. - Form 483, 2024-09-12
June, 2024 FDA 483 Silgan Unicep Packaging, LLC. - Form 483, 2024-06-14
July, 2024 FDA 483 Bhargava Phytolab Private Limited - Form 483, 2024-07-26
October, 2024 FDA 483 Westwood Laboratories, LLC. - Form 483, 2024-10-31
July, 2024 FDA 483 DIVI'S LABORATORIES LIMITED - Form 483, 2024-07-19
January, 2025 FDA 483 Private Label Partners, Inc. - Form 483, 2025-01-17
July, 2025 FDA 483 UCSF Radiopharmaceutical Facility - Form 483, 2025-07-24
August, 2025 FDA 483 Beckman Research Institute of City of Hope - Form 483, 2025-08-20

Experience Redica Systems’ NEW investigator profiles and dashboards

Redica Systems customers get access to over 1,400 FDA Investigator profiles, containing powerful analysis like:

  • Total inspections conducted
  • 483 rate
  • OAI rate
  • Warning Letter rate
  • Inspections by Industry, Scope, and Inspection Reason
  • And much more

Investigator Profiles are not sold as on-demand documents. If you’d like to see one, fill out the form below to connect with our Sales Team and get it in your inbox as little as 24 hours.

FDA Investigator Profile Icon

Talk to sales to access our investigator profiles

Loading...

Investigator Profiles Are Just the Tip of the Iceberg

Becoming a Redica Systems customer not only provides you with unlimited access to profiles similar to the one above for every current and former FDA Investigator, but also grants you access to:

Inspection Intelligence

  • Pre-Approval Inspection (PAI) trends
  • The ability to filter nearly any FDA enforcement action by GxP labels like GMP, GCP, etc.
  • Latest 483s: see what the trends are across all FDA Investigators
  • CFR Heatmap: Citations aggregated by Subpart by Year

Vendor Intelligence

  • Full inspection histories for your vendors down to the specific site level
  • All of the functionality mentioned above but isolated to just your vendors

Regulatory Intelligence

  • Zero in on the trends for a specific agency/regulator (ex. FDA, MHRA, EMA, Health Canada)
  • All the latest "Signals" from agencies around the world, segmented by Country, Type (ex. Guidance, Decree...), Category (ex. Rules/Regulations/Guidance, News, Reports...), Theme (ex. Cell and Gene Therapy, AI...), and more