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FDA Inspection
•SOCIETAL CDMO SAN DIEGO, LLC•August 28, 2026

SOCIETAL CDMO SAN DIEGO, LLC – FDA Inspection, Aug 28, 2026

Record Details

This FDA Inspection record concerns SOCIETAL CDMO SAN DIEGO, LLC, with an inspection on August 28, 2026, issued by the Los Angeles District Office, covering human drugs.

Company
SOCIETAL CDMO SAN DIEGO, LLC
Inspection Date
August 28, 2026
Product Type
Human Drugs
Office
Los Angeles District Office
People
  • Andrew Le (FDA Associated Person)
  • Desiree D. Clark (FDA Associated Person)
  • Devinree T Matticiri (Issuing Officer)
  • Devisree P. Mattigiri (Issuing Officer)
  • Ngozi G. Offor (Company Rep)
  • Sangeeta M. Khurana (FDA Associated Person)
View Company Profile

ID · 6619faab-f42a-4ff8-b9cf-0d2e2bd69fb7

Inspection Facts

Inspection number
1333550
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued, view the record

FDA Citations

3
  1. 21 CFR 211.192Investigations of discrepancies, failures
  2. 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
  3. 21 CFR 211.84(d)(6)Microbiological Contamination Exam

Full citation text and observation details available on the Dashboard.

Other FDA inspections of SOCIETAL CDMO SAN DIEGO, LLC

7
DateClassificationOfficeProject area
January 25, 2023VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
March 13, 2018VAICenter for Drug Evaluation and ResearchGeneric Drug Evaluation
September 4, 2015NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
May 11, 2012VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
October 21, 2011OAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 7 other inspections on the company page
Other documents for SOCIETAL CDMO SAN DIEGO, LLC
  • FDA Inspection 1195503 - 2023-01-25
  • FDA Inspection 1044479 - 2018-03-13
  • FDA Inspection 942176 - 2015-09-04
  • FDA Inspection 781501 - 2012-05-11
  • FDA Inspection 750598 - 2011-10-21

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