INGENUE CARE
Form 483 issued December 6, 2018 · Norwalk, California
- Inspection
- Nov 16 – Dec 6, 2018
- Investigator
- Jolanna A. Norton
- Observations
- 2
- Pages
- 4
In short: On December 6, 2018, FDA issued a Form 483 with 2 observations to INGENUE CARE in Norwalk, California after an inspection that ran Nov 16 – Dec 6, 2018. The investigator was Jolanna A. Norton. 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.
Most cited: 21 CFR 211.165 (1×) · 211.166 (1×)
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
There is no written testing program designed to assess the stability…
This inspection in context
Jolanna A. Norton
22 documents · 2017–2026
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
The firmINGENUE CARE 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 INGENUE CARE?
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 INGENUE CARE?
Jolanna A. Norton is named on this Form 483, for the inspection of Nov 16 – Dec 6, 2018. Each investigator has a profile showing what they cite most.
When was INGENUE CARE inspected by FDA?
The inspection ran Nov 16 – Dec 6, 2018, and the Form 483 is dated December 6, 2018.
How do I get the full Form 483 for INGENUE CARE?
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.