FDA Person
FDARumany C. Penn
View detailed information about Rumany C. Penn, including compliance records, violations, and related data.
Person Profile
FDA investigator. Took part in 35 inspections of 35 companies, 2016–2019.
Inspections (35)
| Date | Company | Classification | Project area | Inspection |
|---|---|---|---|---|
| July 24, 2019 | Shandong Luxi Pharmaceutical Co., Ltd. | VAI | Drug Quality Assurance | #1099165 |
| July 16, 2019 | Zhuhai United Laboratories Co. Ltd. | OAI | Drug Quality Assurance | #1098866 |
| May 24, 2019 | Strides Pharma Science Limited | VAI | Drug Quality Assurance | #1091356 |
| May 15, 2019 | Lupin Ltd. | Not classified | Drug Quality Assurance | #1090546 |
| March 29, 2019 | Taisho Pharmaceutical Co., Ltd. | VAI | Drug Quality Assurance | #1087840 |
| March 22, 2019 | International Chemical Entity Japan Co., Ltd. | VAI | Drug Quality Assurance | #1087385 |
| March 15, 2019 | Enprani Co., Ltd. | OAI | Drug Quality Assurance | #1085302 |
| January 25, 2019 | Indoco Remedies Limited (Plant I) | Not classified | Drug Quality Assurance | #1077464 |
| January 15, 2019 | Dr Reddy's Laboratories Limited | VAI | Drug Quality Assurance | #1076343 |
| November 13, 2018 | Advanced Botanical Consulting & Testing, LLC | OAI | Drug Quality Assurance | #1072344 |
| October 11, 2018 | Algunas Inc., dba Woodland Hills Compounding Pharmacy | VAI | Drug Quality Assurance | #1069078 |
| September 27, 2018 | Asclemed USA Inc. dba Enovachem Pharmaceuticals | OAI | Drug Quality Assurance | #1067059 |
| August 23, 2018 | ASP Cares | OAI | Drug Quality Assurance | #1062902 |
| August 3, 2018 | Haringa Inc dba Premier Packaging Assembly | VAI | Drug Quality Assurance | #1061460 |
| July 20, 2018 | Analytical Resource Laboratories LLC | VAI | Drug Quality Assurance | #1060583 |
| June 22, 2018 | Finorga SAS | NAI | Drug Quality Assurance | #1061010 |
| June 13, 2018 | Servipac | VAI | Drug Quality Assurance | #1058424 |
| April 20, 2018 | Optum Compounding Services, LLC | VAI | Drug Quality Assurance | #1048973 |
| March 23, 2018 | Deseret Laboratories, Inc. | VAI | Drug Quality Assurance | #1045816 |
| March 6, 2018 | The Micro Connection Enterprises, Inc. DBA Personal Care Performance Group | VAI | Drug Quality Assurance | #1043391 |
Documents (42)
- 483 · AnazaoHealth Corporation · March 24, 2017
- 483 · Avella of Deer Valley, Inc. Store 38 · April 20, 2018
- 483 · well care discount pharmacy llc · May 12, 2016
- 483 · Unknown Company · May 11, 2017
- 483 · University Rx Specialist, dba University Compounding Pharmacy · October 27, 2017
- 483 · Algunas Inc., dba Woodland Hills Compounding Pharmacy · October 11, 2018
- 483 · ASP Cares · August 23, 2018
- 483 · Lupin Ltd. · May 15, 2019
- UNTITLED LETTER · Barclay, Luke, & Pillai Specialty Pharmacy, PLLC · December 9, 2022
- STATE REFERRAL LETTER · Barclay, Luke, & Pillai Specialty Pharmacy, PLLC · November 28, 2022
- STATE REFERRAL LETTER · Hiers Enterprises, LLC dba Northwest Compounding Pharmacy · November 2, 2021
- STATE REFERRAL LETTER · ACRX Specialty Pharmacy Inc · July 12, 2021
- 483 · One Way Drug, LLC · July 19, 2017
- WARNING LETTER · Umbrella · May 18, 2021
- WARNING LETTER · Generitech Corporation · July 28, 2021
- WARNING LETTER · Genlabs Corporation · December 9, 2021
- WARNING LETTER · Honest Globe, Inc. · October 8, 2019
- WARNING LETTER · Purechempros LLC · November 22, 2022
- 483 · International Chemical Entity Japan Co., Ltd. · March 18, 2019
- EIR · Shandong Luxi Pharmaceutical Co., Ltd. · July 24, 2019
- 483 · Shandong Luxi Pharmaceutical Co., Ltd. · July 24, 2019
- 483 · Indoco Remedies Limited (Plant I) · January 25, 2019
- 483 · Nissui Corporation · November 11, 2022
- EIR · Deseret Laboratories, Inc. · March 23, 2018
- 483 · NuCare Pharmaceuticals Inc · January 10, 2020
- 483 · Bachem Americas, Inc. · December 10, 2019
- 483 · Taisho Pharmaceutical Co., Ltd. · March 25, 2019
- 483 · Nitto Avecia Pharma Services, Inc. · January 24, 2020
- 483 · Zhuhai United Laboratories Co. Ltd. · July 16, 2019
- 483 · TECHNICHEM CORP · March 18, 2020
- 483 · Enprani Co., Ltd. · March 11, 2019
- 483 · Eisai Company Ltd. · November 1, 2022
- 483 · Asclemed USA Inc. dba Enovachem Pharmaceuticals · September 25, 2018
- 483 · Deseret Laboratories, Inc. · March 23, 2018
- 483 · Innovative Intrathecal Solutions, Inc. dba Innovative Compounding Pharmacy · February 20, 2020
- 483 · Dr Reddy's Laboratories Limited · January 15, 2019
- 483 · Advanced Botanical Consulting & Testing, LLC · November 13, 2018
- 483 · Charles River Laboratories Ireland Ltd. · October 18, 2019
- 483 · Eisai Co., Ltd. Kashima Plant · November 14, 2022
- EIR · Harmony Foods, LLC. dba SCN BestCo · June 9, 2016
- 483 · Strides Pharma Science Limited · May 24, 2019
- 483 · Validation Systems Inc · April 13, 2017
Frequently inspected with (10)
Ashar P. Parikh
3 shared
Eileen A. Liu
3 shared
Justin A. Boyd
Research Specialist II
2 shared
Lucila B. Nwatu
National Program Expert- Pharmacy Compounding
2 shared
Christopher M. Reed
1 shared
James A. Lane
Investigator
1 shared
Kristin M. Abaonza
1 shared
Nayan J. Patel
Senior Lead Reviewer and Intercenter Consult Team Leader
1 shared
Raquel Gonzalez Rivera
Investigator
1 shared
Santiago Gallardo Johnson
https://www.fda.gov/media/120628/download
1 shared
Person Information
Name
Rumany C. Penn
Title
Compliance Officer
Role
Regulatory Personnel
ID: 021eb1e0-8de0-403f-9596-3e76624b2e5a
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