# Office of Regulatory Affairs

Source: https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64
Abbreviation: ORA
Location: Owings Mills, Maryland, USA

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## Details

- Dependent Locality:  
- Postal Code: 21117
- Thoroughfare: 11155 Dolfield Boulevard
- Premise: Suite 117
- Office URL: https://www.fda.gov/about-fda/fda-organization/office-regulatory-affairs
- Created At: 2024-09-13T03:04:10+00:00

## Records at this office

- [Mylan Laboratories Limited](https://www.keypedia.com/records/483/mylan-laboratories-limited/1b851ed2-a51f-4583-a5fc-46d5c3d0ab99)
- [Pharma Nobis LLC](https://www.keypedia.com/records/483/pharma-nobis-llc/650a9902-3af3-44d7-b349-cf07d8630e26)
- [Granules Pharmaceuticals Inc.](https://www.keypedia.com/records/483/granules-pharmaceuticals-inc/d8b4fccb-5ec0-4d32-b070-267fbae547e0) — date: April 3, 2026
- [Aphena Pharma Solutions-Maryland LLC](https://www.keypedia.com/records/483/aphena-pharma-solutions-maryland-llc/f9cf7982-d7c3-4ceb-94e8-81f2da6bd523) — date: February 20, 2026
- [Automated Ophthalmics, Inc.](https://www.keypedia.com/records/483/automated-ophthalmics-inc/d6f029de-e4c3-494d-8c66-1ae75501d0e1) — date: February 13, 2026
- [Bioreliance Corporation](https://www.keypedia.com/records/483/bioreliance-corporation/672a1c90-d840-45b0-bc88-e5785ab1771d) — date: January 29, 2026
- [Mylan, Inc. A Viatris Company](https://www.keypedia.com/records/483/mylan-inc-a-viatris-company/c874bf1c-0324-471a-a5ab-14f60501112a) — date: December 22, 2025
- [CSL Plasma Inc.](https://www.keypedia.com/records/483/csl-plasma-inc/a631303f-fb3b-45fa-a2de-017990f73d5c) — date: December 1, 2025
- [Washington Fertility Center](https://www.keypedia.com/records/483/washington-fertility-center/2bd3fa37-c3e9-4473-95d7-5feb35d526a9) — date: October 23, 2025
- [Hetero Labs Ltd. - Unit IX](https://www.keypedia.com/records/483/hetero-labs-ltd-unit-ix/1122e056-7a9c-4b0e-aaa0-2b2217353a70) — date: September 26, 2025
- [Naval Medical Center Portsmouth](https://www.keypedia.com/records/483/naval-medical-center-portsmouth/0af82382-5589-44a2-85cf-f40325558747) — date: September 25, 2025
- [INOVA Health Care Services Blood Donor Services](https://www.keypedia.com/records/483/inova-health-care-services-blood-donor-services/d11ef9f8-5ced-4c60-9576-6811fcab2c63) — date: September 25, 2025
- [Collaborative Laboratory Services, LLC- Saint Francis Campus](https://www.keypedia.com/records/483/collaborative-laboratory-services-llc-saint-francis-campus/7775aaac-4e3a-4327-888e-62f2268ef07e) — date: August 20, 2025
- [IVF/ART Laboratories/JHH at Green Spring Station](https://www.keypedia.com/records/483/ivfart-laboratoriesjhh-at-green-spring-station/e0cc7e65-c35d-45d9-9bc8-871c3ff5fc38) — date: August 14, 2025
- [Lupin Limited](https://www.keypedia.com/records/483/lupin-limited/f4979117-c0b8-4ccb-bdf3-d5cab68eacb0) — date: July 17, 2025
- [Granules Pharmaceuticals Inc.](https://www.keypedia.com/records/483/granules-pharmaceuticals-inc/903c5e10-6a83-4038-a7fa-4a6b00d240b1) — date: June 27, 2025
- [Noble Life Sciences, Inc](https://www.keypedia.com/records/483/noble-life-sciences-inc/f83f5f74-409a-439f-b49a-824cfd8855b1) — date: June 20, 2025
- [Fareva Richmond, Inc.](https://www.keypedia.com/records/483/fareva-richmond-inc/16029ddc-b85d-4a42-a28c-5ef85eed5b77) — date: May 23, 2025
- [Barr Laboratories Inc.](https://www.keypedia.com/records/483/barr-laboratories-inc/b793dc2e-2608-4d3a-83f0-ffc8d10b5f86) — date: May 9, 2025
- [Shilpa Pharma Lifesciences Limited](https://www.keypedia.com/records/483/shilpa-pharma-lifesciences-limited/3e64a072-7d40-4535-8b7c-f87bd119528b) — date: March 7, 2025

_452 total records — see https://www.keypedia.com/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64 for paginated browsing._

## Related Offices

- [Office of Compliance Intervention and Consultation](https://www.keypedia.com/offices/office-of-compliance-intervention-and-consultation/0b3cfe41-f423-41e0-b1a1-caab23b32d54)
- [Acting Division Director](https://www.keypedia.com/offices/acting-division-director/94758cee-45fe-4207-8c63-497d74b732b6)
- [Bureau of Environmental Health](https://www.keypedia.com/offices/bureau-of-environmental-health/87a06a18-caf6-42b9-8dd5-f53ec7a64384)
- [Division of Nonprescription Drug Products](https://www.keypedia.com/offices/division-of-nonprescription-drug-products/f89a77f0-4378-476b-b846-97563e1b959d)
- [Division of Reproductive and Urologic Products](https://www.keypedia.com/offices/division-of-reproductive-and-urologic-products/29137540-95d5-48bc-a13a-501ed2bf9c3f)

## Officers

- [Consumer Safety Officer](https://www.keypedia.com/people/mark-w-jackson/d4c56fee-b58d-4f39-aa7a-996f86282cc3)
- [Investigator at US FDA](https://www.keypedia.com/people/nichole-b-murphy/c5be04d9-93d7-4f44-85be-5a836e346bc3)
- [Investigator](https://www.keypedia.com/people/lareese-k-thomas/758b3873-995f-4df3-80f6-658c70f23379)
- [Lisa M. Althar](https://www.keypedia.com/people/lisa-m-althar/1f4c853f-2b5d-44c0-9b64-5ff14fbd74bc)
- [Deputy Regional Food and Drug Director](https://www.keypedia.com/people/bruce-i-skolnick/a6684964-ae91-4dfe-88b1-d16a4053c379)
- [Food & Beverages Professional](https://www.keypedia.com/people/haba-cuc-v-barrera/64a94942-77d4-4ebd-8539-5ae51519c941)
- [Investigator](https://www.keypedia.com/people/anthony-n-onianwa/910dd164-8542-4259-b11f-ea3a3f6d7baa)
- [Commissioned Officer](https://www.keypedia.com/people/bary-h-phillipes/d8435af2-bfa5-475a-9fa5-52dc18de43f2)
- [Consumer Safety Officer](https://www.keypedia.com/people/arie-c-menachem/01bacbef-a3ae-4eb0-a56f-e8a70b67a524)
- [CSO at FDA](https://www.keypedia.com/people/justine-m-corson/5f6e4477-f060-47f1-9165-a63fd6a36226)