Formulation Technology Incorporated
Form 483 issued November 9, 2023 · Oakdale, California
- Inspection
- May 16 – Nov 9, 2023
- Investigators
- Ashley J. Allen Gaines· Breena L. Dambrogi· Duc-Minh H. Nguyen
- Observations
- 2
- Pages
- 40
- FEI number
- 2937960
In short: On November 9, 2023, FDA issued a Form 483 with 2 observations to Formulation Technology Incorporated in Oakdale, California (FEI 2937960) after an inspection that ran May 16 – Nov 9, 2023. The investigators were Ashley J. Allen Gaines, Breena L. Dambrogi, Duc-Minh H. Nguyen, Tomanik Le Banks and Tomanik'e C. Banks. Most observations concern food CGMP / preventive controls; the most-cited regulation is 21 CFR 117.35 (sanitary operations).
At a glance
2 of 2 observations on this 483 concern food cgmp / preventive controls.
Most cited: 21 CFR 117.35 (1×) · 21 CFR 117.93 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You did not exclude pests from your food plant to protect…
- 0221 CFR 117.93
You did not store or transport a food under conditions…
This inspection in context
Ashley J. Allen Gaines
1 document · 2023
Cites 117.35 (sanitary operations) more than any other section. Most of their documents are for sites in California.
The firmFormulation Technology Incorporated history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 117.35
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Formulation Technology Incorporated?
FDA listed 2 observations on this Form 483, mostly about food CGMP / preventive controls. The most-cited regulation is 21 CFR 117.35 (sanitary operations). The opening words of each observation are shown on this page.
Who inspected Formulation Technology Incorporated?
Ashley J. Allen Gaines, Breena L. Dambrogi, Duc-Minh H. Nguyen, Tomanik Le Banks and Tomanik'e C. Banks are named on this Form 483, for the inspection of May 16 – Nov 9, 2023. Each investigator has a profile showing what they cite most.
When was Formulation Technology Incorporated inspected by FDA?
The inspection ran May 16 – Nov 9, 2023, and the Form 483 is dated November 9, 2023.
How do I get the full Form 483 for Formulation Technology Incorporated?
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