Ajinomoto Althea, Inc.
Form 483 issued May 18, 2015 · San Diego, California
- Inspection
- May 6 – May 18, 2015
- Investigator
- Joey V. Quitania
- Observations
- 2
- Pages
- 2
- FEI number
- 3004575449
In short: On May 18, 2015, FDA issued a Form 483 with 2 observations to Ajinomoto Althea, Inc. in San Diego, California (FEI 3004575449) after an inspection that ran May 6 – May 18, 2015. The investigator was Joey V. Quitania. Most observations concern production and materials; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and materials account for 2 of 2 observations.
Most cited: 21 CFR 211.113 (1×) · 211.84 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Establishment ofthe reliability of the component supplier's report of analyses is deficient in that file test…
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 211.113
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 production and materials. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Ajinomoto Althea, Inc.?
Joey V. Quitania is named on this Form 483, for the inspection of May 6 – May 18, 2015. Each investigator has a profile showing what they cite most.
When was Ajinomoto Althea, Inc. inspected by FDA?
The inspection ran May 6 – May 18, 2015, and the Form 483 is dated May 18, 2015.
How do I get the full Form 483 for Ajinomoto Althea, 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.