Quotient Sciences - Philadelphia, LLC
Form 483 issued October 27, 2023 · Garnet Valley, Pennsylvania
- Inspection
- Oct 20 – Oct 27, 2023
- Investigator
- Brandy N. Lepage
- Observations
- 2
- Pages
- 5
- FEI number
- 3014679374
In short: On October 27, 2023, FDA issued a Form 483 with 2 observations to Quotient Sciences - Philadelphia, LLC in Garnet Valley, Pennsylvania (FEI 3014679374) after an inspection that ran Oct 20 – Oct 27, 2023. The investigator was Brandy N. Lepage. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.63 (equipment design, size, and location).
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.63 (1×) · 211.67 (1×)
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
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment…
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
The site's inspection history, in date order.
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. The most-cited regulation is 21 CFR 211.63 (equipment design, size, and location). The opening words of each observation are shown on this page.
Who inspected Quotient Sciences - Philadelphia, LLC?
Brandy N. Lepage is named on this Form 483, for the inspection of Oct 20 – Oct 27, 2023. Each investigator has a profile showing what they cite most.
When was Quotient Sciences - Philadelphia, LLC inspected by FDA?
The inspection ran Oct 20 – Oct 27, 2023, and the Form 483 is dated October 27, 2023.
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.