Quotient Sciences - Philadelphia, LLC
FDA inspection history across 2 sites, 2022 to 2025
- 3
- Form 483s
Every document, by year
- Form 483
2022: two Form 483s; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022Two Form 483s, at Boothwyn, Pennsylvania and Garnet Valley, Pennsylvania.
- 2025One Form 483, at Boothwyn, Pennsylvania.
- 2025The longest 483 on file: 3 observations over 4 pages at Boothwyn, Pennsylvania.
Cited most
Across all Quotient Sciences - Philadelphia observations on file
- 21 CFR 211.67Equipment cleaning and maintenance4
- 21 CFR 211.192Production record review1
- 21 CFR 211.28(a)Personnel responsibilities1
- 21 CFR 211.63Equipment design, size, and location1
The complete Quotient Sciences - Philadelphia file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Boothwyn, Pennsylvania
Two Form 483s · 2022 to 2025 · 4 observations
Latest: Form 483, Sep 17, 2025 →Garnet Valley, Pennsylvania
One Form 483 · 2022 · 2 observations
Latest: Form 483, Aug 16, 2022 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-09-17 | 483 Form 483 | Boothwyn, Pennsylvania | 3 | $99 |
| 2022-12-22 | 483 Form 483 | Boothwyn, Pennsylvania | 1 | $99 |
| 2022-08-16 | 483 Form 483 | Garnet Valley, Pennsylvania | 2 | $99 |
Investigators on these documents
Anastasia M. Shields (2)Brandy N. Lepage (1)Christina K. Theodorou (1)Kristina L. Conroy (1)Ruben C. Quintana (1)
FEI number 3003882011 · most recent document Sep 17, 2025
About Quotient Sciences - Philadelphia, LLC
How many FDA Form 483s has Quotient Sciences - Philadelphia, LLC received?
FDA Intel has 3 Form 483s on file for Quotient Sciences - Philadelphia, LLC; the most recent is dated Sep 17, 2025.
When was Quotient Sciences - Philadelphia, LLC last inspected by FDA?
The most recent FDA inspection document on file for Quotient Sciences - Philadelphia, LLC is a Form 483 dated Sep 17, 2025, for the site in Boothwyn, Pennsylvania.
What did FDA cite at Quotient Sciences - Philadelphia, LLC?
The regulations cited most in the observations on file for Quotient Sciences - Philadelphia, LLC are 21 CFR 211.67 (Equipment cleaning and maintenance), 4 times; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.28(a) (Personnel responsibilities), 1 time.