Adaptimmune LLC
Form 483 issued April 5, 2024 · Philadelphia, Pennsylvania
- Inspection
- Apr 1 – Apr 5, 2024
- Investigators
- Anna Kwilas· Elvira Argus· Viviana Ramirez
- Observations
- 5
- Pages
- 4
- FEI number
- 3013525969
In short: On April 5, 2024, FDA issued a Form 483 with 5 observations to Adaptimmune LLC in Philadelphia, Pennsylvania (FEI 3013525969) after an inspection that ran Apr 1 – Apr 5, 2024. The investigators were Anna Kwilas, Elvira Argus and Viviana Ramirez. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and materials account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There are multiple instances in which the root causes identified from deviation investigations are not adequately…
- 02
There are deficiencies in the incoming testing of critical…
- 03
Deviations and/or observations that occur during manufacturing are not always documented appropriately…
- 04
Defined procedures for retesting for Out of Specification results…
This inspection in context
Anna Kwilas
3 documents · 2022–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmAdaptimmune LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Adaptimmune LLC?
FDA listed 5 observations on this Form 483, mostly about quality system, materials and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Adaptimmune LLC?
Anna Kwilas, Elvira Argus and Viviana Ramirez are named on this Form 483, for the inspection of Apr 1 – Apr 5, 2024. Each investigator has a profile showing what they cite most.
When was Adaptimmune LLC inspected by FDA?
The inspection ran Apr 1 – Apr 5, 2024, and the Form 483 is dated April 5, 2024.
How do I get the full Form 483 for Adaptimmune 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.