AVKARE LLC
Form 483 issued November 2, 2022 · Pulaski, Tennessee
- Inspection
- Oct 31 – Nov 2, 2022
- Investigator
- Santos E. Camara
- Observations
- 1
- Pages
- 3
- FEI number
- 3007255004
In short: On November 2, 2022, FDA issued a Form 483 with 1 observation to AVKARE LLC in Pulaski, Tennessee (FEI 3007255004) after an inspection that ran Oct 31 – Nov 2, 2022. The investigator was Santos E. Camara. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Santos E. Camara
33 documents · 2015–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmAVKARE LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AVKARE LLC?
FDA listed 1 observation 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 AVKARE LLC?
Santos E. Camara is named on this Form 483, for the inspection of Oct 31 – Nov 2, 2022. Each investigator has a profile showing what they cite most.
When was AVKARE LLC inspected by FDA?
The inspection ran Oct 31 – Nov 2, 2022, and the Form 483 is dated November 2, 2022.
How do I get the full Form 483 for AVKARE LLC?
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.