Form 483 · FEI 3008322822
Form 483 issued January 31, 2025
- Inspection
- Jan 23 – Jan 31, 2025
- Investigators
- Thai D. Truong· Travis S. Bradley
- Observations
- 2
- Pages
- 3
- FEI number
- 3008322822
In short: On January 31, 2025, FDA issued a Form 483 with 2 observations to an FDA-inspected site (FEI 3008322822) after an inspection that ran Jan 23 – Jan 31, 2025. The investigators were Thai D. Truong and Travis S. Bradley. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 1 system, led by quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Discrepancy and failure investigations related to manufacturing were not expanded to…
- 02
Procedures for the acceptance and rejection of components and materials utilized within drug substance…
This inspection in context
Thai D. Truong
12 documents · 2022–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.
The firmSite 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 an FDA-inspected site?
FDA listed 2 observations on this Form 483, mostly about quality system. 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 an FDA-inspected site?
Thai D. Truong and Travis S. Bradley are named on this Form 483, for the inspection of Jan 23 – Jan 31, 2025. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Jan 23 – Jan 31, 2025, and the Form 483 is dated January 31, 2025.
How do I get the full Form 483 for an FDA-inspected site?
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.