FDA Person
Office of the CommissionerMichael R. Klapal
View detailed information about Michael R. Klapal, including compliance records, violations, and related data.
Person Profile
FDA investigator, Office of the Commissioner. Took part in 4 inspections of 3 companies, 2017–2019.
Inspections (4)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| April 16, 2019 | KVK Tech, Inc. | OAI | Generic Drug Evaluation | #1086467 |
| May 17, 2018 | Advanced Accelerator Applications USA, Inc. | Not classified | #1054683 | |
| February 9, 2018 | Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) | Not classified | #1045220 | |
| June 27, 2017 | KVK Tech, Inc. | VAI | Drug Quality Assurance | #1016049 |
Documents (11)
- 483 · ImprimisRx NJ · August 19, 2013
- WARNING LETTER · Pfizer Healthcare India Private Limited · September 6, 2019
- 483 RESPONSE · ImprimisRx NJ · August 19, 2013
- EIR · Ashland Specialty Ingredients · July 11, 2013
- EIR · Catalent Belgium SA · August 19, 2022
- EIR · SGS Life Sciences Services · July 20, 2012
- EIR · ImClone Systems, LLC · July 10, 2015
- 483 · Vetter Pharma Fertigung GmbH & Co. KG (Ravensburg Mooswiesen) · February 9, 2018
- 483 · SGS Life Sciences Services · July 20, 2012
- 483 · KVK Tech, Inc. · April 16, 2019
- EIR · Gibraltar Laboratories, Inc. · February 3, 2015
Frequently inspected with (7)
Related Office
Person Information
Name
Michael R. Klapal
Title
Investigator
Role
Regulatory Personnel
ID: b181b5e8-4fc3-48ed-b17c-791359e7b619
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