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FDA Inspection
•Pasadena Hospital Association, Ltd.•September 12, 2025

Pasadena Hospital Association, Ltd. – FDA Inspection, Sep 12, 2025

Record Details

This FDA Inspection record concerns Pasadena Hospital Association, Ltd., with an inspection on September 12, 2025, issued by the Los Angeles District Office, covering biologics.

Company
Pasadena Hospital Association, Ltd.
Inspection Date
September 12, 2025
Product Type
Biologics
Office
Los Angeles District Office
Person
  • Amy W. Yan-Mai (Issuing Officer)
View Company Profile

ID · 7bac3bef-d607-4a76-b2a8-3ea762378f8c

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1281286
FDA center
Biologics
Project area
Blood and Blood Products
Outcome
Form 483 issued

FDA Citations

2
  1. 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs
  2. 21 CFR 606.160(a)(1)Person performing, test results, interpretation

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Pasadena Hospital Association, Ltd.

5
DateClassificationOfficeProject area
April 29, 2021NAICenter for Biologics Evaluation and ResearchVaccines and Allergenic Products
September 25, 2017NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
November 14, 2014VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
October 30, 2012NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
March 18, 2011NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
Other documents for Pasadena Hospital Association, Ltd.
  • FDA Inspection 1142054 - 2021-04-29
  • FDA Inspection 1028063 - 2017-09-25
  • FDA Inspection 904912 - 2014-11-14
  • FDA Inspection 806131 - 2012-10-30
  • FDA Inspection 715080 - 2011-03-18

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