Quotient Sciences - Philadelphia, LLC
Form 483 issued September 17, 2025 · Boothwyn, Pennsylvania
- Inspection
- Sep 8 – Sep 17, 2025
- Investigators
- Anastasia M. Shields· Ruben C. Quintana
- Observations
- 3
- Pages
- 4
- FEI number
- 3003882011
In short: On September 17, 2025, FDA issued a Form 483 with 3 observations to Quotient Sciences - Philadelphia, LLC in Boothwyn, Pennsylvania (FEI 3003882011) after an inspection that ran Sep 8 – Sep 17, 2025. The investigators were Anastasia M. Shields and Ruben C. Quintana. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
2 of 3 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
- 02
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that…
- 03
Protective apparel is not worn as necessary to protect…
This inspection in context
Anastasia M. Shields
45 documents · 2016–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in India.
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 211.67(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Quotient Sciences - Philadelphia, LLC?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Quotient Sciences - Philadelphia, LLC?
Anastasia M. Shields and Ruben C. Quintana are named on this Form 483, for the inspection of Sep 8 – Sep 17, 2025. Each investigator has a profile showing what they cite most.
When was Quotient Sciences - Philadelphia, LLC inspected by FDA?
The inspection ran Sep 8 – Sep 17, 2025, and the Form 483 is dated September 17, 2025.
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.