Atlas Analytical Inc
Form 483 issued November 14, 2019 · Brooksville, Florida
- Inspection
- Nov 12 – Nov 14, 2019
- Investigators
- Amir Alavi· Saundrea A. Munroe· Walden H. Lee
- Observations
- 5
- Pages
- 5
- FEI number
- 3014434540
In short: On November 14, 2019, FDA issued a Form 483 with 5 observations to Atlas Analytical Inc in Brooksville, Florida (FEI 3014434540) after an inspection that ran Nov 12 – Nov 14, 2019. The investigators were Amir Alavi, Saundrea A. Munroe and Walden H. Lee. Most observations concern quality system and laboratory controls.
At a glance
3 of 5 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
The accuracy, specificity and reproducibility of test methods…
- 02
Established test procedures and laboratory control…
- 03
Written records of major equipment maintenance are not included…
- 04
Complaint records are deficient in that they do not include the findings of the…
This inspection in context
Amir Alavi
9 documents · 2017–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmAtlas Analytical Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Atlas Analytical Inc?
FDA listed 5 observations on this Form 483, mostly about quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Atlas Analytical Inc?
Amir Alavi, Saundrea A. Munroe and Walden H. Lee are named on this Form 483, for the inspection of Nov 12 – Nov 14, 2019. Each investigator has a profile showing what they cite most.
When was Atlas Analytical Inc inspected by FDA?
The inspection ran Nov 12 – Nov 14, 2019, and the Form 483 is dated November 14, 2019.
How do I get the full Form 483 for Atlas Analytical 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.