Drug factory · FDA FEI 3004575449

PCI San Diego, Inc.

11040 Roselle Street, San Diego, CA, United States

Problems found, fixed voluntarily at FDA's last inspection, May 9, 2025.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

11 drug inspections on record since 2008: 4 with no problems, 7 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Adalimumab	Makes it	Meitheal Pharmaceuticals Inc.	71288-815, 71288-816, 71288-817 +1
Botulinum Toxin Type A	Makes it	Revance Therapeutics, Inc.	72960-112
Efbemalenograstim Alfa	Makes it and tests it	Acrotech Biopharma Inc	72893-016
Elamipretide	Makes it and tests it	Stealth Biotherapeutics Inc.	72507-800
Fulvestrant	Makes it	Glenmark Pharmaceuticals Inc., USA	68462-317
Givosiran	Makes it	Alnylam Pharmaceuticals, Inc.	71336-1001
Ibritumomab Tiuxetan	Makes it	Acrotech Biopharma Inc	72893-007
Lerodalcibep	Makes it	LIB Therapeutics, Inc.	84685-300
Lumasiran	Makes it	Alnylam Pharmaceuticals, Inc.	71336-1002
Nalmefene	Makes it	Knoa Pharma LLC	59011-960
Nogapendekin Alfa Inbakicept-Pmln	Makes it	Altor BioScience, LLC, an indirect wholly-owned subsidiary of ImmunityBio, Inc.	81481-803
Obiltoxaximab	Makes it and tests it	Elusys Therapeutics, Inc.	69604-204
Patisiran	Makes it	Alnylam Pharmaceuticals, Inc.	71336-1000
Teplizumab	Makes it and tests it	Provention Bio, Inc.	73650-316

Ended	Result	Program	Problems noted
May 9, 2025	Problems found, fixed voluntarily	Drug Quality Assurance	6
Sep 20, 2023	Problems found, fixed voluntarily	Drug Quality Assurance	—
May 25, 2021	Problems found, fixed voluntarily	Drug Quality Assurance	—
Nov 22, 2019	Problems found, fixed voluntarily	Drug Quality Assurance	—
Aug 7, 2019	Problems found, fixed voluntarily	Drug Quality Assurance	—
Apr 6, 2017	Problems found, fixed voluntarily	Drug Quality Assurance	3
May 18, 2015	Problems found, fixed voluntarily	Drug Quality Assurance	—
Nov 15, 2013	No problems found	Drug Quality Assurance	—
Jul 18, 2012	No problems found	Drug Quality Assurance	—
Aug 1, 2011	No problems found	Drug Quality Assurance	—
Oct 23, 2008	No problems found	Drug Quality Assurance	—

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.
Validation lacking for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process.
Scientifically sound laboratory controls 21 CFR 211.160(b)
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
No written record of investigation 21 CFR 211.192
Written records are not always made of investigations into unexplained discrepancies.
Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
Cleaning System 21 CFR 211.42(c)(10)(v)
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.

Following/documenting laboratory controls 21 CFR 211.160(a)
Established laboratory control mechanisms are not followed.
Lab controls established, including changes 21 CFR 211.160(a)
The establishment of laboratory control mechanisms including any changes thereto, are not reviewed and approved by the quality control unit.
Written procedures fail to include 21 CFR 211.67(b)
Written procedures for cleaning and maintenance fail to include parameters relevant to the operation.

Registered with FDA for: analysis; manufacture.