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FDA Inspection
•Quotient Sciences - Philadelphia, LLC•October 27, 2023

Quotient Sciences - Philadelphia, LLC – FDA Inspection, Oct 27, 2023

Record Details

This FDA Inspection record concerns Quotient Sciences - Philadelphia, LLC, with an inspection on October 27, 2023, issued by the Philadelphia District Office.

Company
Quotient Sciences - Philadelphia, LLC
Inspection Date
October 27, 2023
Office
Philadelphia District Office
Person
  • Brandy N. Lepage (FDA Associated Person)
View Company Profile

ID · fe2281a8-6500-4f1b-992f-3c71692577a2

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
1221172
FDA center
Human Drugs
Outcome
Form 483 issued

FDA Citations

2
  1. 21 CFR 211.63Equipment Design, Size and Location
  2. 21 CFR 211.67(b)Written procedures fail to include

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Quotient Sciences - Philadelphia, LLC

1
DateClassificationOfficeProject area
March 2, 2026Not classifiedPhiladelphia District Office
Other documents for Quotient Sciences - Philadelphia, LLC
  • FDA Inspection 1311618 - 2026-03-02

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