Helio USA Inc.
FDA inspection history in San Jose, California, 2015 to 2016
- 2
- Form 483s
Every document, by year
- Form 483
2015: one Form 483; 2016: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–16Two Form 483s, at San Jose, California.
- 2015The longest 483 on file: 22 observations over 8 pages at San Jose, California.
Cited most
Across all Helio USA observations on file
- 21 CFR 820.30(a)Design controls9
- 21 CFR 820.100(a)Corrective and preventive action4
- 21 CFR 820.198(a)Complaint files4
- 21 CFR 820.150Storage2
- 21 CFR 820.186Quality system record2
The complete Helio USA file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
San Jose, California
Two Form 483s · 2015 to 2016 · 36 observations
Latest: Form 483, Jul 6, 2016 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-07-06 | 483 Form 483 | San Jose, California | 14 | $99 |
| 2015-05-12 | 483 Form 483 | San Jose, California | 22 | $99 |
Investigators on these documents
FEI number 1000135119 · most recent document Jul 6, 2016
About Helio USA Inc.
How many FDA Form 483s has Helio USA Inc. received?
FDA Intel has 2 Form 483s on file for Helio USA Inc.; the most recent is dated Jul 6, 2016.
When was Helio USA Inc. last inspected by FDA?
The most recent FDA inspection document on file for Helio USA Inc. is a Form 483 dated Jul 6, 2016, for the site in San Jose, California.
What did FDA cite at Helio USA Inc.?
The regulations cited most in the observations on file for Helio USA Inc. are 21 CFR 820.30(a) (Design controls), 9 times; 21 CFR 820.100(a) (Corrective and preventive action), 4 times; 21 CFR 820.198(a) (Complaint files), 4 times.