2seventy bio
Form 483 issued March 20, 2025 · Cambridge, Massachusetts
- Inspection
- Mar 17 – Mar 20, 2025
- Investigator
- Scott Ballard
- Observations
- 1
- Pages
- 2
- FEI number
- 3013427685
In short: On March 20, 2025, FDA issued a Form 483 with 1 observation to 2seventy bio in Cambridge, Massachusetts (FEI 3013427685) after an inspection that ran Mar 17 – Mar 20, 2025. The investigator was Scott Ballard. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.194 (laboratory records).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.194 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory records do not include complete records of any testing and standardization…
This inspection in context
Scott Ballard
30 documents · 2011–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firm2seventy bio history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at 2seventy bio?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.194 (laboratory records). The opening words of each observation are shown on this page.
Who inspected 2seventy bio?
Scott Ballard is named on this Form 483, for the inspection of Mar 17 – Mar 20, 2025. Each investigator has a profile showing what they cite most.
When was 2seventy bio inspected by FDA?
The inspection ran Mar 17 – Mar 20, 2025, and the Form 483 is dated March 20, 2025.
How do I get the full Form 483 for 2seventy bio?
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.