Avella of Deer Valley, Inc.
Form 483 issued April 19, 2018 · Phoenix, Arizona
- Inspection
- Apr 17, 2020
- Investigators
- Marijo B. Kambere· Sangeeta M. Khurana
- Observations
- 3
- Pages
- 4
- FEI number
- 3006345305
In short: On April 19, 2018, FDA issued a Form 483 with 3 observations to Avella of Deer Valley, Inc. in Phoenix, Arizona (FEI 3006345305) after an inspection that ran Apr 17, 2020. The investigators were Marijo B. Kambere and Sangeeta M. Khurana. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and production account for 2 of 3 observations.
Most cited: 21 CFR 211.22 (1×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment…
- 03
CMPl OYEE(S) SIGNAl'URE…
This inspection in context
Marijo B. Kambere
11 documents · 2015–2021
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in China.
The firmAvella of Deer Valley, Inc. history
All 8 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 Avella of Deer Valley, Inc.?
FDA listed 3 observations on this Form 483, mostly about quality system and production. 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 Avella of Deer Valley, Inc.?
Marijo B. Kambere and Sangeeta M. Khurana are named on this Form 483, for the inspection of Apr 17, 2020. Each investigator has a profile showing what they cite most.
When was Avella of Deer Valley, Inc. inspected by FDA?
The inspection ran Apr 17, 2020, and the Form 483 is dated April 19, 2018.
How do I get the full Form 483 for Avella of Deer Valley, 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.