Epic Pharmaz LLC
Form 483 issued June 4, 2015 · Laurelton, New York
- Inspection
- May 21 – Jun 4, 2015
- Investigator
- Demitria J. Xiradakis
- Observations
- 5
- Pages
- 4
- FEI number
- 2431929
In short: On June 4, 2015, FDA issued a Form 483 with 5 observations to Epic Pharmaz LLC in Laurelton, New York (FEI 2431929) after an inspection that ran May 21 – Jun 4, 2015. The investigator was Demitria J. Xiradakis. Most observations concern production and materials; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
3 of 5 observations on this 483 concern production.
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 04
In-process materials are not tested for identity, strength, quality, and purity and approved or rejected by…
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 firmEpic Pharmaz LLC history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Epic Pharmaz LLC?
FDA listed 5 observations on this Form 483, mostly about production, materials and laboratory controls. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Epic Pharmaz LLC?
Demitria J. Xiradakis is named on this Form 483, for the inspection of May 21 – Jun 4, 2015. Each investigator has a profile showing what they cite most.
When was Epic Pharmaz LLC inspected by FDA?
The inspection ran May 21 – Jun 4, 2015, and the Form 483 is dated June 4, 2015.
How do I get the full Form 483 for Epic Pharmaz 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.