Proteus Digital Health
Form 483 issued March 11, 2016 · Hayward, California
- Inspection
- Mar 1 – Mar 11, 2016
- Investigators
- Mariappan V. Chelliah· Seema S. Singh
- Observations
- 1
- Pages
- 2
- FEI number
- 3010742884
In short: On March 11, 2016, FDA issued a Form 483 with 1 observation to Proteus Digital Health in Hayward, California (FEI 3010742884) after an inspection that ran Mar 1 – Mar 11, 2016. The investigators were Mariappan V. Chelliah and Seema S. Singh. Most observations concern design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
1 of 1 observations on this 483 concern design controls.
Most cited: 21 CFR 820.30 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for design verification…
This inspection in context
Mariappan V. Chelliah
1 document · 2016
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in California.
The firmProteus Digital Health history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Proteus Digital Health?
FDA listed 1 observation on this Form 483, mostly about design controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Proteus Digital Health?
Mariappan V. Chelliah and Seema S. Singh are named on this Form 483, for the inspection of Mar 1 – Mar 11, 2016. Each investigator has a profile showing what they cite most.
When was Proteus Digital Health inspected by FDA?
The inspection ran Mar 1 – Mar 11, 2016, and the Form 483 is dated March 11, 2016.
How do I get the full Form 483 for Proteus Digital Health?
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.