Atlas Pharmaceuticals, LLC
Form 483 issued September 26, 2017 · Phoenix, Arizona
- Inspection
- Aug 15, 2017 – Sep 26, 2020
- Investigator
- Stephanie A. Slater
- Observations
- 11
- Pages
- 15
- FEI number
- 3013030904
In short: On September 26, 2017, FDA issued a Form 483 with 11 observations to Atlas Pharmaceuticals, LLC in Phoenix, Arizona (FEI 3013030904) after an inspection that ran Aug 15, 2017 – Sep 26, 2020. The investigator was Stephanie A. Slater. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Observations span 4 systems, led by facilities & equipment.
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 ofdrug products purporting to be sterile are not…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
There is a lack of written procedures describing in sufficient detail the methods, equipment and materials…
- 04
Employees engaged in the manufacture, processing, packing and holding of a drug product lack the education…
This inspection in context
Stephanie A. Slater
20 documents · 2015–2021
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in California.
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 11 observations on this Form 483, mostly about facilities & equipment, laboratory controls and production. 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?
Stephanie A. Slater is named on this Form 483, for the inspection of Aug 15, 2017 – Sep 26, 2020. Each investigator has a profile showing what they cite most.
When was Atlas Pharmaceuticals, LLC inspected by FDA?
The inspection ran Aug 15, 2017 – Sep 26, 2020, and the Form 483 is dated September 26, 2017.
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.