ECI Pharmaceuticals LLC
Form 483 issued February 27, 2015 · Ft. Lauderdale, Florida
- Inspection
- Feb 2 – Feb 27, 2015
- Investigator
- Ileana Barreto-Pettit
- Observations
- 4
- Pages
- 2
- FEI number
- 3008798439
In short: On February 27, 2015, FDA issued a Form 483 with 4 observations to ECI Pharmaceuticals LLC in Ft. Lauderdale, Florida (FEI 3008798439) after an inspection that ran Feb 2 – Feb 27, 2015. The investigator was Ileana Barreto-Pettit. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and quality system account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
The establishment of specifications including any changes thereto, are not reviewed and approved by…
- 03
Master production and control records lack a specimen or copy of each label and all other…
- 04
Representative samples are not taken of each shipment of each lot of components…
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 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ECI Pharmaceuticals LLC?
FDA listed 4 observations on this Form 483, mostly about production, quality system and materials. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected ECI Pharmaceuticals LLC?
Ileana Barreto-Pettit is named on this Form 483, for the inspection of Feb 2 – Feb 27, 2015. Each investigator has a profile showing what they cite most.
When was ECI Pharmaceuticals LLC inspected by FDA?
The inspection ran Feb 2 – Feb 27, 2015, and the Form 483 is dated February 27, 2015.
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.