Manna Omni International, Inc
Form 483 issued September 24, 2020 · Fullerton, California
- Inspection
- Sep 23 – Sep 24, 2020
- Investigator
- Alan L. Truong
- Observations
- 2
- Pages
- 3
- FEI number
- 3005155593
In short: On September 24, 2020, FDA issued a Form 483 with 2 observations to Manna Omni International, Inc in Fullerton, California (FEI 3005155593) after an inspection that ran Sep 23 – Sep 24, 2020. The investigator was Alan L. Truong. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
2 of 2 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
Results of stability testing are not used in determining appropriate storage…
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 firmManna Omni International, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Manna Omni International, Inc?
FDA listed 2 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Manna Omni International, Inc?
Alan L. Truong is named on this Form 483, for the inspection of Sep 23 – Sep 24, 2020. Each investigator has a profile showing what they cite most.
When was Manna Omni International, Inc inspected by FDA?
The inspection ran Sep 23 – Sep 24, 2020, and the Form 483 is dated September 24, 2020.
How do I get the full Form 483 for Manna Omni International, 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.