FDA Person
Office of the CommissionerAnita R. Michael
View detailed information about Anita R. Michael, including compliance records, violations, and related data.
Person Profile
FDA investigator, Office of the Commissioner. Took part in 16 inspections of 16 companies, 2017–2018.
Inspections (16)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| April 24, 2018 | PPL Healthcare LLC | VAI | Drug Quality Assurance | #1053485 |
| March 5, 2018 | Janssen Biotech, Inc. | VAI | Drug Quality Assurance | #1046499 |
| January 26, 2018 | GlaxoSmithKline, LLC. | VAI | Drug Quality Assurance | #1043309 |
| November 6, 2017 | Quotient Sciences - Philadelphia, LLC | VAI | Generic Drug Evaluation | #1030748 |
| September 6, 2017 | Marlex Pharmaceuticals, Inc. | NAI | Drug Quality Assurance | #1028879 |
| August 24, 2017 | AstraZeneca Pharmaceuticals, LP | NAI | Foodborne Biological Hazards | #1022686 |
| July 31, 2017 | Vegewax Candleworx Ltd. | VAI | Drug Quality Assurance | #1019962 |
| July 26, 2017 | Novocol Pharmaceutical of Canada, Inc. | VAI | Postmarket Surv. and Epidemiology | #1019963 |
| July 20, 2017 | Du-Var Laboratory | VAI | Drug Quality Assurance | #1019961 |
| July 7, 2017 | Kenvue Brands LLC | VAI | Drug Quality Assurance | #1017380 |
| June 29, 2017 | SaveWay Compounding Pharmacy, Inc. | VAI | Drug Quality Assurance | #1016126 |
| May 19, 2017 | Cardinal Health 414 LLC | NAI | Drug Quality Assurance | #1021720 |
| April 12, 2017 | Auxilium Pharmaceuticals, Inc. | VAI | Drug Quality Assurance | #1017587 |
| March 2, 2017 | Sulzbach Enterprises, Inc. | VAI | Monitoring of Marketed Animal Drugs, Feed, and Devices | #1009738 |
| February 14, 2017 | Boiron Inc. | NAI | Drug Quality Assurance | #1007059 |
| January 17, 2017 | Accugenix LLC | NAI | Drug Quality Assurance | #1007057 |
Documents (25)
- 483 · Home Infusions Solutions, Inc. · May 21, 2013
- 483 · Kenvue Brands LLC · December 9, 2010
- 483 · SaveWay Compounding Pharmacy, Inc. · June 29, 2017
- 483 · US Specialty Formulations LLC · May 29, 2015
- 483 · Central Admixture Pharmacy Services, Inc. · November 20, 2015
- 483 · Jeffreys Drug Store · February 9, 2016
- 483 · Kenvue Brands LLC · January 12, 2006
- 483 · Pentec Health · April 1, 2013
- 483 · Kenvue Brands LLC · April 30, 2010
- 483 · Johnson & Johnson Consumer, Inc · July 9, 2010
- 483 · Central Admixture Pharmacy Services, Inc. · June 11, 2014
- 483 · Janssen Biotech, Inc. · March 5, 2018
- 483 · Frontage Laboratories, Inc. · March 17, 2016
- EIR · Steven J. Glass, M.D. · January 26, 2009
- 483 · Janssen Biotech, Inc. · May 18, 2017
- EIR · Eurofins Lancaster Laboratories, Inc · June 19, 2015
- EIR · Altasciences CDMO Philadelphia, LLC · March 16, 2011
- EIR · Alliance Contract Pharma · February 18, 2014
- 483 · PPL Healthcare LLC · April 24, 2018
- 483 · Kenvue Brands LLC · July 7, 2017
- EIR · SPI Pharma, Inc. · August 24, 2016
- 483 · GlaxoSmithKline, LLC. · January 25, 2018
- EIR · Kenvue Brands LLC · July 7, 2017
- EIR · PPL Healthcare LLC · April 24, 2018
- EIR · Bio Agri Mix LP · July 22, 2016
Frequently inspected with (2)
Related Office
Person Information
Name
Anita R. Michael
Title
Investigator
Role
Regulatory Personnel
ID: b7699b1a-4157-477e-8226-2cfc906fc61d
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