Helio USA Inc.
Form 483 issued July 6, 2016 · San Jose, California
- Inspection
- Jun 27 – Jul 6, 2016
- Investigator
- Mary R. Hole
- Observations
- 14
- Pages
- 7
- FEI number
- 1000135119
In short: On July 6, 2016, FDA issued a Form 483 with 14 observations to Helio USA Inc. in San Jose, California (FEI 1000135119) after an inspection that ran Jun 27 – Jul 6, 2016. The investigator was Mary R. Hole. Most observations concern cAPA and design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
CAPA and design controls account for 9 of 14 observations.
What FDA observed
Preview: the opening words of each observation- 01
Not all complaints have been reviewed and evaluated to determine whether…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 03
The written MDR procedure does not include documentation and recordkeeping requirements for all information that was…
- 04
Procedures for corrective and preventive action have…
This inspection in context
Mary R. Hole
7 documents · 2013–2017
Cites 820.30 (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 820.198(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Helio USA Inc.?
FDA listed 14 observations on this Form 483, mostly about cAPA, design controls and records & documents. 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.?
Mary R. Hole is named on this Form 483, for the inspection of Jun 27 – Jul 6, 2016. Each investigator has a profile showing what they cite most.
When was Helio USA Inc. inspected by FDA?
The inspection ran Jun 27 – Jul 6, 2016, and the Form 483 is dated July 6, 2016.
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.