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
FDA Investigators that have inspected at least one site in common with Andrew Le:
Alan P Kurtzberg,
Alicia K Mckinsey,
Anastasia M Shields,
Angela E Glenn,
Anh M Lac,
Anita Narula, PhD,
Anney Lin,
Arsen Karapetyan,
Ashar P Parikh,
Barbara Janine Breithaupt,
Barbara M Frazier,
Binh T Nguyen,
Bryan L Mcguckin,
Caryn M Mcnab,
Cheryl A Clausen,
Christopher D Leach,
Claudia Mperez Kasmarski,
Courtney N Long,
Dandan Wang, PhD,
Darren S Brown,
Deborah A Greco,
Debra I Love,
Diane Cvan Leeuwen,
Esther B Gamallo Herrera,
Feiyan Jin,
Helen Verdel,
Henry K Lau,
Hung H Do, MS,
Jeffrey M Watson,
Jeffrey P Raimondi,
Jennifer C Adams,
Joey V Quitania,
John A Gonzalez,
Jolanna A Norton,
Jose R Hernandez,
Junho Pak,
Kham Phommachanh,
Khoa Nathanv Tran,
Kim Lthomas Cruse,
LCDR Jennifer H Rhyu,
Linda M Cheny,
Lisa Shin,
Makini Cobourne Duval, PhD,
Marijo B Kambere, PhD,
Matthew B Casale,
Melkamu Getie Kebtie, PhD,
Nayan J Patel,
Nicholas A Violand,
Paraluman S Leonin,
Parul M Patel,
Phillip L Toy,
Pratik S Upadhyay, DDC,
Rafeeq A Habeeb,
Robert J Doyle,
S Lori Brown, PhD MPH,
Sangeeta M Khurana, PhD,
Santiago Gallardo Johnson,
Sharon K Thoma, PharmD,
Stacey S Degarmo,
Taichun Qin, PhD,
Tamil Arasu, PhD,
Tenzin Jangchup,
Thomas J Arista,
Tracey T Duong,
Tracy K Li,
Truong Xuan Nguyen (Andy),
Virgilio F Pacio, CSO,
Zachary A Bogorad,
Zachary L Miller,
Zachary L Stamm
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 |
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.
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