ECI Pharmaceuticals LLC
Form 483 issued November 18, 2016 · Ft. Lauderdale, Florida
- Inspection
- Nov 7 – Nov 18, 2016
- Investigators
- Ileana Barreto-Pettit· Jennifer Lalama
- Observations
- 6
- Pages
- 7
- FEI number
- 3008798439
In short: On November 18, 2016, FDA issued a Form 483 with 6 observations to ECI Pharmaceuticals LLC in Ft. Lauderdale, Florida (FEI 3008798439) after an inspection that ran Nov 7 – Nov 18, 2016. The investigators were Ileana Barreto-Pettit and Jennifer Lalama. Most observations concern facilities & equipment and production.
At a glance
4 of 6 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The in process control procedures were deficient in that they did not include an examination of…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
- 04
Equipment for adequate control over air pressure and dust is not provided when appropriate for the…
This inspection in context
Ileana Barreto-Pettit
25 documents · 2001–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Florida.
The firmECI Pharmaceuticals LLC history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ECI Pharmaceuticals LLC?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected ECI Pharmaceuticals LLC?
Ileana Barreto-Pettit and Jennifer Lalama are named on this Form 483, for the inspection of Nov 7 – Nov 18, 2016. Each investigator has a profile showing what they cite most.
When was ECI Pharmaceuticals LLC inspected by FDA?
The inspection ran Nov 7 – Nov 18, 2016, and the Form 483 is dated November 18, 2016.
How do I get the full Form 483 for ECI Pharmaceuticals 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.