Overview
- 9 FDA inspections are on record.
- 4 inspections produced a Form 483.
- The most recent recorded inspection date is 2025-09-17.
At a glance
Inspections
9
Form 483s
4
EIRs
2
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 8 Sep 2025 – 17 Sep 2025 | Human Drugs | 483 | View 483 → |
| 14 Dec 2022 – 22 Dec 2022 | Human Drugs | 483 | View 483 → |
| 24 Oct 2017 – 6 Nov 2017 | Human Drugs | 483 | View 483 → |
| 24 May 2016 – 31 May 2016 | Human Drugs | Clean | |
| 26 Oct 2015 – 2 Nov 2015 | Human Drugs | 483 | On file |
| 11 Jun 2015 – 12 Jun 2015 | Human Drugs | Clean | |
| 5 Nov 2013 – 7 Nov 2013 | Human Drugs | Clean | |
| 12 Jan 2012 | Not recorded | Clean | |
| 9 Sep 2010 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
17 Sep 2025
21 CFR 211.28(a)
Protective Apparel Not Worn
Cited by Anastasia M Shields, Ruben C Quintana
17 Sep 2025
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Anastasia M Shields, Ruben C Quintana
17 Sep 2025
21 CFR 211.67(b)
Written procedures not established/followed
Cited by Anastasia M Shields, Ruben C Quintana
22 Dec 2022
21 CFR 211.67(a)
Cleaning / Sanitizing / Maintenance
Cited by Anastasia M Shields, Kristina L Conroy
Investigators
FDA investigators tied to this site in the record.
Anita R Michael6 insp.
Anastasia M Shields2 insp.
Ruben C Quintana1 insp.
Kristina L Conroy1 insp.
Craig D Zagata1 insp.
Lisa B Orr1 insp.
Thomas E Friel1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 211.63 | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.80(b) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 211.67(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 211.28(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 211.67(b) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Quotient Sciences - Philadelphia, LLC's 4 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat