Advanced Therapies, LLC
Form 483 issued September 1, 2023 · Philadelphia, Pennsylvania
- Inspection
- Aug 28 – Sep 1, 2023
- Investigators
- Brian Niland· Grace Forsythia Cortesini· Hector Carrero
- Observations
- 1
- Pages
- 2
- FEI number
- 1000122198
In short: On September 1, 2023, FDA issued a Form 483 with 1 observation to Advanced Therapies, LLC in Philadelphia, Pennsylvania (FEI 1000122198) after an inspection that ran Aug 28 – Sep 1, 2023. The investigators were Brian Niland, Grace Forsythia Cortesini, Hector Carrero and Karin Knudson. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×) · 211.25 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The aseptic operator qualification…
This inspection in context
Brian Niland
1 document · 2023
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmAdvanced Therapies, 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 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Advanced Therapies, LLC?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Advanced Therapies, LLC?
Brian Niland, Grace Forsythia Cortesini, Hector Carrero and Karin Knudson are named on this Form 483, for the inspection of Aug 28 – Sep 1, 2023. Each investigator has a profile showing what they cite most.
When was Advanced Therapies, LLC inspected by FDA?
The inspection ran Aug 28 – Sep 1, 2023, and the Form 483 is dated September 1, 2023.
How do I get the full Form 483 for Advanced Therapies, 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.