CustomceuticaJ Compounding, LLC
Form 483 issued March 8, 2019 · Phoenix, Arizona
- Inspection
- Feb 27 – Mar 8, 2019
- Investigators
- Christopher M. Jenner· Nicholas L. Hunt
- Observations
- 5
- Pages
- 4
- FEI number
- 3014083318
In short: On March 8, 2019, FDA issued a Form 483 with 5 observations to CustomceuticaJ Compounding, LLC in Phoenix, Arizona (FEI 3014083318) after an inspection that ran Feb 27 – Mar 8, 2019. The investigators were Christopher M. Jenner and Nicholas L. Hunt. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
3 of 5 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42 (3×) · 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…
- 02
Aseptic processing areas are deficient regarding the systems for environmental monitoring conditions and actionable microbial contamination…
- 03
Clothing of personnel engaged in the production of drug products intended to be sterile is not…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Christopher M. Jenner
11 documents · 2017–2022
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Arizona.
The firmCustomceuticaJ Compounding, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CustomceuticaJ Compounding, LLC?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected CustomceuticaJ Compounding, LLC?
Christopher M. Jenner and Nicholas L. Hunt are named on this Form 483, for the inspection of Feb 27 – Mar 8, 2019. Each investigator has a profile showing what they cite most.
When was CustomceuticaJ Compounding, LLC inspected by FDA?
The inspection ran Feb 27 – Mar 8, 2019, and the Form 483 is dated March 8, 2019.
How do I get the full Form 483 for CustomceuticaJ Compounding, 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.