Honest Globe, Inc
Form 483 issued October 8, 2019 · Santa Ana, California
- Inspection
- Oct 4 – Oct 8, 2019
- Investigator
- Alan L. Truong
- Observations
- 9
- Pages
- 7
- FEI number
- 3015667771
In short: On October 8, 2019, FDA issued a Form 483 with 9 observations to Honest Globe, Inc in Santa Ana, California (FEI 3015667771) after an inspection that ran Oct 4 – Oct 8, 2019. The investigator was Alan L. Truong. Most observations concern quality system and production.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Records are not maintained so that data therein can be reviewed at least annually to evaluate…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
- 04
Written records are not made of investigations into unexplained discrepancies and the failure of a batch…
This inspection in context
Alan L. Truong
16 documents · 2019–2025
Cites 211.188 (batch production and control records) more than any other section. Most of their documents are for sites in California.
The firmHonest Globe, 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 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Honest Globe, Inc?
FDA listed 9 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Honest Globe, Inc?
Alan L. Truong is named on this Form 483, for the inspection of Oct 4 – Oct 8, 2019. Each investigator has a profile showing what they cite most.
When was Honest Globe, Inc inspected by FDA?
The inspection ran Oct 4 – Oct 8, 2019, and the Form 483 is dated October 8, 2019.
How do I get the full Form 483 for Honest Globe, 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.