Quotient Sciences - Philadelphia, LLC
Form 483 issued August 16, 2022 · Garnet Valley, Pennsylvania
- Inspection
- Aug 5 – Aug 16, 2022
- Investigators
- Brandy N. Lepage· Christina K. Theodorou
- Observations
- 2
- Pages
- 4
- FEI number
- 3014679374
In short: On August 16, 2022, FDA issued a Form 483 with 2 observations to Quotient Sciences - Philadelphia, LLC in Garnet Valley, Pennsylvania (FEI 3014679374) after an inspection that ran Aug 5 – Aug 16, 2022. The investigators were Brandy N. Lepage and Christina K. Theodorou. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
There is a failure to thoroughly review whether or not the batch has been…
This inspection in context
Brandy N. Lepage
31 documents · 2021–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmQuotient Sciences - Philadelphia, LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.63
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Quotient Sciences - Philadelphia, LLC?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Quotient Sciences - Philadelphia, LLC?
Brandy N. Lepage and Christina K. Theodorou are named on this Form 483, for the inspection of Aug 5 – Aug 16, 2022. Each investigator has a profile showing what they cite most.
When was Quotient Sciences - Philadelphia, LLC inspected by FDA?
The inspection ran Aug 5 – Aug 16, 2022, and the Form 483 is dated August 16, 2022.
How do I get the full Form 483 for Quotient Sciences - Philadelphia, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.