DNA Pharmacy Services Inc dba Palm Beach Compounding
Form 483 issued August 13, 2014 · Jupiter, Florida
- Inspection
- Aug 11 – Aug 13, 2014
- Investigator
- Justine C. Tomasso
- Observations
- 3
- Pages
- 1
- FEI number
- 3004962739
In short: On August 13, 2014, FDA issued a Form 483 with 3 observations to DNA Pharmacy Services Inc dba Palm Beach Compounding in Jupiter, Florida (FEI 3004962739) after an inspection that ran Aug 11 – Aug 13, 2014. The investigator was Justine C. Tomasso. Most observations concern laboratory controls and facilities & equipment.
At a glance
2 of 3 observations on this 483 concern laboratory controls.
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 designed to assess the…
- 02
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to…
- 03
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the…
This inspection in context
Justine C. Tomasso
5 documents · 2012–2025
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Florida.
The firmDNA Pharmacy Services Inc dba Palm Beach Compounding history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at DNA Pharmacy Services Inc dba Palm Beach Compounding?
FDA listed 3 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected DNA Pharmacy Services Inc dba Palm Beach Compounding?
Justine C. Tomasso is named on this Form 483, for the inspection of Aug 11 – Aug 13, 2014. Each investigator has a profile showing what they cite most.
When was DNA Pharmacy Services Inc dba Palm Beach Compounding inspected by FDA?
The inspection ran Aug 11 – Aug 13, 2014, and the Form 483 is dated August 13, 2014.
How do I get the full Form 483 for DNA Pharmacy Services Inc dba Palm Beach Compounding?
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.