Japan Food Research Laboratories
Form 483 issued March 29, 2023 · Ibaraki, Osaka, Japan
- Inspection
- Mar 27 – Mar 29, 2023
- Investigator
- Saied A. Asbagh
- Observations
- 5
- Pages
- 3
- FEI number
- 3004579906
In short: On March 29, 2023, FDA issued a Form 483 with 5 observations to Japan Food Research Laboratories in Ibaraki, Osaka, Japan (FEI 3004579906) after an inspection that ran Mar 27 – Mar 29, 2023. The investigator was Saied A. Asbagh. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
3 of 5 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
Employees are not given training in the particular operations they perform as…
- 02
The quality control unit lacks authority to fully investigate…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Determinations of conformance to appropriate written specifications for acceptance are deficient in that they are not…
This inspection in context
Saied A. Asbagh
12 documents · 2016–2024
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in California.
The firmJapan Food Research Laboratories history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.25(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Japan Food Research Laboratories?
FDA listed 5 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Japan Food Research Laboratories?
Saied A. Asbagh is named on this Form 483, for the inspection of Mar 27 – Mar 29, 2023. Each investigator has a profile showing what they cite most.
When was Japan Food Research Laboratories inspected by FDA?
The inspection ran Mar 27 – Mar 29, 2023, and the Form 483 is dated March 29, 2023.
How do I get the full Form 483 for Japan Food Research Laboratories?
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.