FDA Person
FDAFrank Wackes
View detailed information about Frank Wackes, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 4 inspections of 4 companies, 2016–2017.
Inspections (4)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| March 24, 2017 | Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P. | OAI | Compliance: Devices | #1007608 |
| March 10, 2017 | Sigma-Aldrich Manufacturing LLC | VAI | Drug Quality Assurance | #1010226 |
| January 20, 2017 | Nephron Sc Inc | NAI | Generic Drug Evaluation | #1006544 |
| December 1, 2016 | Kimball Electronics - Indianapolis | VAI | Drug Quality Assurance | #1000623 |
Documents (6)
- 483 · Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P. · March 4, 2013
- 483 · Meridian Medical Technologies, LLC a Subsidiary of Kindeva Drug Delivery, L.P. · March 24, 2017
- WARNING LETTER · Aqualex Co., Ltd. · October 20, 2023
- EIR · Nephron Pharmaceuticals Corp. · January 20, 2017
- EIR · Nortec Quimica SA · July 22, 2022
- 483 · Curia New York, Inc. · May 18, 2015
Frequently inspected with (10)
Bonita S. Chester
Director of Inspection Readiness
1 shared
Debara R. Reese
1 shared
John C. Mcmichael
Director
1 shared
Kellia N. Hicks
Investigator
1 shared
Kshitij A. Patkar
1 shared
Larry K. Hampton
investigator
1 shared
Michele L. Obert
Program Expert
1 shared
Michele Perry-Williams
Investigator
1 shared
Phillip M. Pontikos
Realtor
1 shared
Rick L. Friedman
Deputy Director
1 shared
Person Information
Name
Frank Wackes
Title
Investigator
Role
Regulatory Personnel
ID: ebbfd9b6-d4e6-4f4d-a071-52e7c46f0b5a
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