FDA Investigator Erik W Koester

Erik W Koester has conducted inspections on 134 sites in 0 countries as of 10 Mar 2025. See below for a list of the FDA enforcement documents resulting from those inspections.

Investigator Details

Number of Inspected Sites:
134
Last Inspection Date:
10 Mar 2025
Investigator Role:
FDA Investigator
Redica ID:
100009538

Erik W Koester's Documents

Publish Date Document Type Title
March, 2025 FDA 483 GC HANFORD MFG CO - Form 483, 2025-03-20
June, 2025 FDA 483 GF Health Products, Inc. - Form 483, 2025-06-05
August, 2025 FDA 483 Hikma Injectables USA Inc. - Form 483, 2025-08-08
July, 2025 FDA 483 Cardinal Health 414, LLC - Form 483, 2025-07-01
November, 2022 FDA 483 Response Pharmaceutics International, Inc. - Form 483R, 2023-01-19
September, 2025 FDA 483 Charles River Laboratories, Inc. - Form 483, 2025-09-09
April, 2025 FDA 483 Viyash Life Sciences Private Limited - Form 483, 2025-04-25
September, 2025 FDA 483 Massachusetts General Hospital, The - Form 483, 2025-09-30
September, 2025 EIR Charles River Laboratories, Inc. - EIR, 2025-09-16
September, 2025 FDA 483 Response Charles River Laboratories, Inc. - Form 483R, 2025-09-25
November, 2024 FDA 483 PolyPeptide Laboratories Private Limited - Form 483, 2024-11-22
November, 2025 FDA 483 PETNET SOLUTIONS, INC. - Form 483, 2025-11-04
April, 2025 FDA 483 Sharon Bio-Medicine Limited - Form 483, 2025-04-18
January, 2026 FDA 483 Anika Therapeutics Inc - Form 483, 2026-01-22
March, 2026 FDA 483 Sharp Sterile Manufacturing, LLC - Form 483, 2026-03-05
April, 2026 FDA 483 Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC - Form 483, 2026-04-08
May, 2026 FDA 483 Cambridge Isotope Laboratories, Inc. - Form 483, 2026-05-22
June, 2026 FDA 483 Fayetteville VA Medical Center - Form 483, 2026-06-15
August, 2026 FDA 483 Auro Peptides Limited - Form 483, 2026-08-21

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