Ajinomoto Althea, Inc.
Form 483 issued August 7, 2019 · San Diego, California
- Inspection
- Jul 30 – Aug 7, 2019
- Investigators
- Joey V. Quitania· Santiago Gallardo Johnson
- Observations
- 2
- Pages
- 3
- FEI number
- 3004575449
In short: On August 7, 2019, FDA issued a Form 483 with 2 observations to Ajinomoto Althea, Inc. in San Diego, California (FEI 3004575449) after an inspection that ran Jul 30 – Aug 7, 2019. The investigators were Joey V. Quitania and Santiago Gallardo Johnson. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The quality control unit lacks the responsibility and authority to approve and…
- 02
Investigations of an unexplained discrepancy and a failure of a batch or any of its components…
This inspection in context
Joey V. Quitania
23 documents · 2009–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmAjinomoto Althea, Inc. history
All 13 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ajinomoto Althea, Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system. 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 Ajinomoto Althea, Inc.?
Joey V. Quitania and Santiago Gallardo Johnson are named on this Form 483, for the inspection of Jul 30 – Aug 7, 2019. Each investigator has a profile showing what they cite most.
When was Ajinomoto Althea, Inc. inspected by FDA?
The inspection ran Jul 30 – Aug 7, 2019, and the Form 483 is dated August 7, 2019.
How do I get the full Form 483 for Ajinomoto Althea, Inc.?
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