Quotient Sciences - Philadelphia, LLC
Form 483 issued December 22, 2022 · Boothwyn, Pennsylvania
- Inspection
- Dec 14 – Dec 22, 2022
- Investigators
- Anastasia M. Shields· Kristina L. Conroy
- Observations
- 1
- Pages
- 3
- FEI number
- 3003882011
In short: On December 22, 2022, FDA issued a Form 483 with 1 observation to Quotient Sciences - Philadelphia, LLC in Boothwyn, Pennsylvania (FEI 3003882011) after an inspection that ran Dec 14 – Dec 22, 2022. The investigators were Anastasia M. Shields and Kristina L. Conroy. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would…
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(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Quotient Sciences - Philadelphia, LLC?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. 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 Kristina L. Conroy are named on this Form 483, for the inspection of Dec 14 – Dec 22, 2022. Each investigator has a profile showing what they cite most.
When was Quotient Sciences - Philadelphia, LLC inspected by FDA?
The inspection ran Dec 14 – Dec 22, 2022, and the Form 483 is dated December 22, 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.