FDA Person
FDAKenneth E. Felkley
View detailed information about Kenneth E. Felkley, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 19 inspections of 18 companies, 2016–2018.
Inspections (19)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| March 27, 2018 | BiB Production & Packaging B.V. | OAI | Drug Quality Assurance | #1047400 |
| March 23, 2018 | Bayer Bitterfeld GmbH | VAI | Drug Quality Assurance | #1048506 |
| March 16, 2018 | Takeda GmbH, Plant Oranienburg | VAI | Drug Quality Assurance | #1047651 |
| February 14, 2018 | Patheon Pharmaceuticals Inc. | VAI | Drug Quality Assurance | #1040994 |
| January 26, 2018 | Teva Womens Health, LLC | VAI | Drug Quality Assurance | #1038720 |
| January 11, 2018 | Nostrum Laboratories, Inc. | NAI | Drug Quality Assurance | #1041315 |
| November 30, 2017 | Cardinal Health 414, LLC | VAI | Drug Quality Assurance | #1036799 |
| November 15, 2017 | American Regent, Inc. | NAI | Drug Quality Assurance | #1035309 |
| August 15, 2017 | Bullet Line LLC | VAI | Drug Quality Assurance | #1021664 |
| June 29, 2017 | Cardinal Health | VAI | Drug Quality Assurance | #1016636 |
| May 24, 2017 | Pharmacy Associates, Inc. dba CompreCare Specialty Pharmacy | VAI | Drug Quality Assurance | #1012574 |
| April 25, 2017 | Advanced Crystal Therapies | VAI | Unapproved and Misbranded Drugs | #1009114 |
| March 15, 2017 | Dixie Dew Products Inc | OAI | Foodborne Biological Hazards | #1004065 |
| March 2, 2017 | Patheon Pharmaceuticals Inc. | VAI | Drug Quality Assurance | #1003802 |
| February 23, 2017 | Pharmacia Hepar, LLC | NAI | Drug Quality Assurance | #1002902 |
| December 8, 2016 | Basic Drugs Inc. dba Basic Vitamins | VAI | Drug Quality Assurance | #994775 |
| December 6, 2016 | RJ General Corporation | NAI | Drug Quality Assurance | #994834 |
| November 10, 2016 | NCS Healthcare of Kentucky Inc | NAI | Drug Quality Assurance | #994832 |
| October 24, 2016 | Avantor Performance Materials LLC | VAI | Drug Quality Assurance | #993761 |
Documents (7)
- 483 · Dixie Dew Products Inc · March 15, 2017
- 483 · Pharmacy Associates, Inc. dba CompreCare Specialty Pharmacy · May 24, 2017
- 483 · Patheon Pharmaceuticals Inc. · February 14, 2018
- EIR · Patheon Pharmaceuticals Inc. · March 1, 2017
- EIR · Patheon Pharmaceuticals Inc. · February 14, 2018
- 483 · Teva Womens Health, LLC · January 26, 2018
- 483 · Takeda GmbH, Plant Oranienburg · March 16, 2018
Frequently inspected with (9)
Lindsey S. Fleischman
issuing_officer
4 shared
Nicholas L. Paulin
4 shared
Mary B. Sheets
Investigator
2 shared
Michael P. Sheehan
General Manager
2 shared
Andrew J. Barrowcliff
1 shared
Andrew M. Kupper
1 shared
Emily J. Stoklosa
1 shared
Heather A. McCauley
Director of Investigations Branch 2
1 shared
Matthew B. Casale
Investigator
1 shared
Person Information
Name
Kenneth E. Felkley
Title
Investigator
Role
Regulatory Personnel
ID: a765e932-11df-406d-ab45-5bf4ac9ff27b
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