Town Total Compounding Center
Form 483 issued April 20, 2016 · Melville, New York
- Inspection
- Apr 4 – Apr 20, 2016
- Investigator
- Demitria J. Xiradakis
- Observations
- 6
- Pages
- 6
- FEI number
- 3012223762
In short: On April 20, 2016, FDA issued a Form 483 with 6 observations to Town Total Compounding Center in Melville, New York (FEI 3012223762) after an inspection that ran Apr 4 – Apr 20, 2016. The investigator was Demitria J. Xiradakis. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Laboratory controls 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
There is no written testing program des igned to assess the stabi lity characteristics of drug…
- 02
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 04
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions. a) Environmental monitoring for…
This inspection in context
Demitria J. Xiradakis
3 documents · 2015–2016
Cites 211.110 (sampling and testing of in-process materials and drug products) more than any other section. Most of their documents are for sites in New York.
The firmTown Total Compounding Center history
All 2 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 Town Total Compounding Center?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, 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 Town Total Compounding Center?
Demitria J. Xiradakis is named on this Form 483, for the inspection of Apr 4 – Apr 20, 2016. Each investigator has a profile showing what they cite most.
When was Town Total Compounding Center inspected by FDA?
The inspection ran Apr 4 – Apr 20, 2016, and the Form 483 is dated April 20, 2016.
How do I get the full Form 483 for Town Total 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.