Custom Compounding Center
Form 483 issued March 30, 2020 · Little Rock, Arkansas
- Inspection
- Mar 30, 2020
- Investigators
- Camerson E. Moore· Jason R. Caballero
- Observations
- 6
- Pages
- 3
- FEI number
- 3002401385
In short: On March 30, 2020, FDA issued a Form 483 with 6 observations to Custom Compounding Center in Little Rock, Arkansas (FEI 3002401385) after an inspection that ran Mar 30, 2020. The investigators were Camerson E. Moore and Jason R. Caballero. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and facilities & equipment account for 4 of 6 observations.
Most cited: 21 CFR 211.42 (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 do not include…
- 02
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air…
- 03
The separate or defined areas and control systems necessary to prevent contamination…
- 04
Protective apparel is not worn as necessary to protect…
This inspection in context
Camerson E. Moore
48 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) 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 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Custom Compounding Center?
FDA listed 6 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. 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 Custom Compounding Center?
Camerson E. Moore and Jason R. Caballero are named on this Form 483, for the inspection of Mar 30, 2020. Each investigator has a profile showing what they cite most.
When was Custom Compounding Center inspected by FDA?
The inspection ran Mar 30, 2020, and the Form 483 is dated March 30, 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.