PCI San Diego, Inc.
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- United States
- Registered address
- 11040 Roselle Street, San Diego, California (CA) 92121, United States (USA)
- Operations here
- analysismanufacture
- FDA identifiers
- FEI 3004575449 · DUNS 023050730
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-05-09
- VAIDrug Quality Assurance2023-09-20
- VAIDrug Quality Assurance2021-05-25
- VAIDrug Quality Assurance2019-08-07
- VAIBlood and Blood Products2019-02-07
- VAIBlood and Blood Products2017-06-01
- VAIDrug Quality Assurance2017-04-06
- VAIBlood and Blood Products2015-08-06
- VAIDrug Quality Assurance2015-05-18
- NAIDrug Quality Assurance2013-11-15
- VAIBlood and Blood Products2013-06-11
- NAIDrug Quality Assurance2012-07-18
- NAIDrug Quality Assurance2011-08-01
- NAIDrug Quality Assurance2008-10-23
Drugs this plant is listed as making
12 distinct drugs across 12 products name this site in their FDA label.
- botulinum toxin type ARevance Therapeutics, Inc.
- efbemalenograstim alfa-vuxwAcrotech Biopharma Inc
- Elamipretide HydrochlorideStealth Biotherapeutics Inc.
- FulvestrantGlenmark Pharmaceuticals Inc., Usa
- givosiran sodiumAlnylam Pharmaceuticals, Inc.
- ibritumomab tiuxetanAcrotech Biopharma Inc
- lumasiranAlnylam Pharmaceuticals, Inc.
- Nalmefene HydrochlorideKnoa Pharma LLC
- nogapendekin alfa inbakicept-pmlnAltor BioScience, LLC, an indirect wholly-owned subsidiary of ImmunityBio, Inc.
- obiltoxaximabElusys Therapeutics, Inc.
- patisiranAlnylam Pharmaceuticals, Inc.
- Sumatriptan SuccinateUpsher-Smith laboratories, LLC
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.