Americare Compounding, LLC
Form 483 issued June 22, 2015 · Garden City South, New York
- Inspection
- Jun 10 – Jun 22, 2015
- Investigator
- James A. Liubicich
- Observations
- 8
- Pages
- 5
- FEI number
- 3010223213
In short: On June 22, 2015, FDA issued a Form 483 with 8 observations to Americare Compounding, LLC in Garden City South, New York (FEI 3010223213) after an inspection that ran Jun 10 – Jun 22, 2015. The investigator was James A. Liubicich. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 6 of 8 observations.
Most cited: 21 CFR 211.42 (4×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 03
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to…
- 04
Clothing of personnel engaged in the processing of drug products is not appropriate for…
This inspection in context
James A. Liubicich
13 documents · 2013–2015
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New York.
The firmAmericare Compounding, LLC history
All 4 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 Americare Compounding, LLC?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, production 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 Americare Compounding, LLC?
James A. Liubicich is named on this Form 483, for the inspection of Jun 10 – Jun 22, 2015. Each investigator has a profile showing what they cite most.
When was Americare Compounding, LLC inspected by FDA?
The inspection ran Jun 10 – Jun 22, 2015, and the Form 483 is dated June 22, 2015.
How do I get the full Form 483 for Americare 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.