Epic Pharmaz LLC
Form 483 issued October 23, 2023 · Laurelton, New York
- Inspection
- Oct 16 – Oct 23, 2023
- Investigators
- Evan Tong· Syeda N. Mahazabin
- Observations
- 1
- Pages
- 3
- FEI number
- 2431929
In short: On October 23, 2023, FDA issued a Form 483 with 1 observation to Epic Pharmaz LLC in Laurelton, New York (FEI 2431929) after an inspection that ran Oct 16 – Oct 23, 2023. The investigators were Evan Tong and Syeda N. Mahazabin. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67(b)(3) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods…
This inspection in context
Evan Tong
6 documents · 2023–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Pennsylvania.
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 211.67(b)(3)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Epic Pharmaz LLC?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Epic Pharmaz LLC?
Evan Tong and Syeda N. Mahazabin are named on this Form 483, for the inspection of Oct 16 – Oct 23, 2023. Each investigator has a profile showing what they cite most.
When was Epic Pharmaz LLC inspected by FDA?
The inspection ran Oct 16 – Oct 23, 2023, and the Form 483 is dated October 23, 2023.
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.