Epic Pharmaz LLC
Form 483 issued February 1, 2019 · Laurelton, New York
- Inspection
- Jan 22 – Feb 1, 2019
- Investigator
- Alice S. Tsao
- Observations
- 6
- Pages
- 6
- FEI number
- 2431929
In short: On February 1, 2019, FDA issued a Form 483 with 6 observations to Epic Pharmaz LLC in Laurelton, New York (FEI 2431929) after an inspection that ran Jan 22 – Feb 1, 2019. The investigator was Alice S. Tsao. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Production and facilities & equipment account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 02
Your examination and testing of samples did not assure that the drug product and in-process…
- 03
Equipment and utensils are not cleaned at appropriate intervals to prevent that would alter the safety…
- 04
Written procedures are lacking which describe in sufficient detail the identification…
This inspection in context
Alice S. Tsao
16 documents · 2011–2023
Cites 211.67 (equipment cleaning and maintenance) 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 211.110(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Epic Pharmaz LLC?
FDA listed 6 observations on this Form 483, mostly about production, facilities & equipment and materials. 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?
Alice S. Tsao is named on this Form 483, for the inspection of Jan 22 – Feb 1, 2019. Each investigator has a profile showing what they cite most.
When was Epic Pharmaz LLC inspected by FDA?
The inspection ran Jan 22 – Feb 1, 2019, and the Form 483 is dated February 1, 2019.
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.