Juno Therapeutics, Inc.
Form 483 issued September 20, 2023 · Bothell, Washington
- Inspection
- Sep 11 – Sep 20, 2023
- Observations
- 3
- Pages
- 4
- FEI number
- 3011834594
In short: On September 20, 2023, FDA issued a Form 483 with 3 observations to Juno Therapeutics, Inc. in Bothell, Washington (FEI 3011834594) after an inspection that ran Sep 11 – Sep 20, 2023. Most observations concern production and quality system.
At a glance
Production and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
This inspection in context
Questions about this 483
What did FDA find at Juno Therapeutics, Inc.?
FDA listed 3 observations on this Form 483, mostly about production, quality system and facilities & equipment. The opening words of each observation are shown on this page.
When was Juno Therapeutics, Inc. inspected by FDA?
The inspection ran Sep 11 – Sep 20, 2023, and the Form 483 is dated September 20, 2023.
How do I get the full Form 483 for Juno Therapeutics, Inc.?
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.