Custom Compounding Center
Form 483 issued June 4, 2020 · Little Rock, Arkansas
- Inspection
- May 29, 2019 – Jun 4, 2020
- Investigator
- Jason R. Caballero
- Observations
- 1
- Pages
- 1
- FEI number
- 3002401385
In short: On June 4, 2020, FDA issued a Form 483 with 1 observation to Custom Compounding Center in Little Rock, Arkansas (FEI 3002401385) after an inspection that ran May 29, 2019 – Jun 4, 2020. The investigator was Jason R. Caballero. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You produced hazardous drugs without provid ing adequate cleaning of work surfaces…
This inspection in context
Jason R. Caballero
26 documents · 2014–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmCustom Compounding Center history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Custom Compounding Center?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Custom Compounding Center?
Jason R. Caballero is named on this Form 483, for the inspection of May 29, 2019 – Jun 4, 2020. Each investigator has a profile showing what they cite most.
When was Custom Compounding Center inspected by FDA?
The inspection ran May 29, 2019 – Jun 4, 2020, and the Form 483 is dated June 4, 2020.
How do I get the full Form 483 for Custom Compounding Center?
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.