Helio USA Inc.
Form 483 issued May 12, 2015 · San Jose, California
- Inspection
- Apr 27 – May 12, 2015
- Investigators
- Mark E. Chan· Mary R. Hole
- Observations
- 22
- Pages
- 8
- FEI number
- 1000135119
In short: On May 12, 2015, FDA issued a Form 483 with 22 observations to Helio USA Inc. in San Jose, California (FEI 1000135119) after an inspection that ran Apr 27 – May 12, 2015. The investigators were Mark E. Chan and Mary R. Hole. Most observations concern production & process controls and design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Observations span 4 systems, led by production & process controls.
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Procedures for acceptance of incoming product have…
- 03
The results of design validates, including identification of the design, method(s), the date, and the individual(s)…
- 04
Procedures to ensure equipment is routinely calibrated have…
This inspection in context
Mark E. Chan
2 documents · 2015
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in California.
The firmHelio USA Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Helio USA Inc.?
FDA listed 22 observations on this Form 483, mostly about production & process controls, design controls and cAPA. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Helio USA Inc.?
Mark E. Chan and Mary R. Hole are named on this Form 483, for the inspection of Apr 27 – May 12, 2015. Each investigator has a profile showing what they cite most.
When was Helio USA Inc. inspected by FDA?
The inspection ran Apr 27 – May 12, 2015, and the Form 483 is dated May 12, 2015.
How do I get the full Form 483 for Helio USA 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.