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FDA Inspection
•APL HEALTHCARE LIMITED•September 19, 2023

APL HEALTHCARE LIMITED – FDA Inspection, Sep 19, 2023

Record Details

This FDA Inspection record concerns APL HEALTHCARE LIMITED, with an inspection on September 19, 2023, issued by the Office of Inspections and Investigations.

Company
APL HEALTHCARE LIMITED
Inspection Date
September 19, 2023
Office
Office of Inspections and Investigations
Person
  • Kellia N. Hicks (FDA Associated Person)
View Company Profile

ID · 2f405ca9-ff8d-49f7-b04a-8bd83309b3eb

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1218204
FDA center
Human Drugs
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 211.192Investigations of discrepancies, failures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of APL HEALTHCARE LIMITED

7
DateClassificationOfficeProject area
December 17, 2025VAIOffice of Inspections and InvestigationsDrug Quality Assurance
February 28, 2020VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
April 19, 2019NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
March 20, 2019NAICenter for Drug Evaluation and ResearchBioresearch Monitoring
October 26, 2018NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
View all 7 other inspections on the company page
Other documents for APL HEALTHCARE LIMITED
  • FDA Inspection 1295002 - 2025-12-17
  • FDA Inspection 1121028 - 2020-02-28
  • FDA Inspection 1090528 - 2019-04-19
  • FDA Inspection 1089710 - 2019-03-20
  • FDA Inspection 1076644 - 2018-10-26

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