SENSONICS, INTERNATIONAL
Form 483 issued February 10, 2025 · Haddon Heights, California
- Inspection
- Jan 29 – Feb 10, 2025
- Investigators
- Jae H. Lee· Kevin N. Tran
- Observations
- 4
- Pages
- 28
- FEI number
- 3012422693
In short: On February 10, 2025, FDA issued a Form 483 with 4 observations to SENSONICS, INTERNATIONAL in Haddon Heights, California (FEI 3012422693) after an inspection that ran Jan 29 – Feb 10, 2025. The investigators were Jae H. Lee and Kevin N. Tran. Most observations concern production & process controls and management controls; the most-cited regulation is 21 CFR 820.50 (purchasing controls).
At a glance
3 of 4 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.50 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for quality audits have…
- 02
Purchasing data that clearly describe or reference sjlecitied requirements for purchased or otherwise received product and…
- 03
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 04
A process whose results cannot be fully verified by subsequent inspection and test has not been…
This inspection in context
Jae H. Lee
3 documents · 2024–2026
Cites 820.50 (purchasing controls) more than any other section. Most of their documents are for sites in California.
The firmSENSONICS, INTERNATIONAL history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.50
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at SENSONICS, INTERNATIONAL?
FDA listed 4 observations on this Form 483, mostly about production & process controls and management controls. The most-cited regulation is 21 CFR 820.50 (purchasing controls). The opening words of each observation are shown on this page.
Who inspected SENSONICS, INTERNATIONAL?
Jae H. Lee and Kevin N. Tran are named on this Form 483, for the inspection of Jan 29 – Feb 10, 2025. Each investigator has a profile showing what they cite most.
When was SENSONICS, INTERNATIONAL inspected by FDA?
The inspection ran Jan 29 – Feb 10, 2025, and the Form 483 is dated February 10, 2025.
How do I get the full Form 483 for SENSONICS, INTERNATIONAL?
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.