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FDA Inspection
•Kareway Product Inc•March 28, 2019

Kareway Product Inc – FDA Inspection, Mar 28, 2019

Record Details

This FDA Inspection record concerns Kareway Product Inc, with an inspection on March 28, 2019, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Kareway Product Inc
Inspection Date
March 28, 2019
Product Type
Drugs
Office
Center for Drug Evaluation and Research
Person
  • Lakecha N. Lewis (FDA Associated Person)
View Company Profile

ID · d933ddb5-d1fa-4fbc-84be-bce0d7f72135

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1084225
FDA center
Human Drugs
Project area
Postmarket Surv. and Epidemiology
Outcome
Form 483 issued

FDA Citations

1
  1. FDCA 760(b)(1)Failure of responsible person to report AE (non-RX Drug)

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Kareway Product Inc

1
DateClassificationOfficeProject area
August 2, 2024NAICenter for Drug Evaluation and ResearchBioresearch Monitoring
Other documents for Kareway Product Inc
  • FDA Inspection 1229679 - 2024-08-02

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