Atlas Pharmaceuticals, LLC
Form 483 issued June 11, 2021 · Phoenix, Arizona
- Inspection
- May 3, 2021
- Investigator
- Nicholas L. Hunt
- Observations
- 3
- Pages
- 5
- FEI number
- 3013030904
In short: On June 11, 2021, FDA issued a Form 483 with 3 observations to Atlas Pharmaceuticals, LLC in Phoenix, Arizona (FEI 3013030904) after an inspection that ran May 3, 2021. The investigator was Nicholas L. Hunt. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
2 of 3 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (2×)
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 sterile are not…
- 02
Determinations of conformance to appropriate written specifications for acceptance are…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
This inspection in context
Nicholas L. Hunt
38 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Arizona.
The firmAtlas Pharmaceuticals, LLC history
All 3 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 Atlas Pharmaceuticals, LLC?
FDA listed 3 observations on this Form 483, mostly about production and laboratory controls. 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 Atlas Pharmaceuticals, LLC?
Nicholas L. Hunt is named on this Form 483, for the inspection of May 3, 2021. Each investigator has a profile showing what they cite most.
When was Atlas Pharmaceuticals, LLC inspected by FDA?
The inspection ran May 3, 2021, and the Form 483 is dated June 11, 2021.
How do I get the full Form 483 for Atlas Pharmaceuticals, 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.