Epic Pharmaz LLC
FDA inspection history in Laurelton, New York, 2015 to 2023
- 3
- Form 483s
Every document, by year
- Form 483
2015: one Form 483; 2019: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One Form 483, at Laurelton, New York.
- 2019One Form 483, at Laurelton, New York.
- 2019The longest 483 on file: 6 observations over 6 pages at Laurelton, New York.
- 2023One Form 483, at Laurelton, New York.
Cited most
Across all Epic Pharmaz observations on file
- 21 CFR 211.110Sampling and testing of in-process materials and drug products4
- 21 CFR 211.67(a)Equipment cleaning and maintenance2
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.142(b)Warehousing procedures1
- 21 CFR 211.160(b)General requirements1
The complete Epic Pharmaz file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Laurelton, New York
Three Form 483s · 2015 to 2023 · 12 observations
Latest: Form 483, Oct 23, 2023 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-10-23 | 483 Form 483 | Laurelton, New York | 1 | $99 |
| 2019-02-01 | 483 Form 483 | Laurelton, New York | 6 | $99 |
| 2015-06-04 | 483 Form 483 | Laurelton, New York | 5 | $99 |
Investigators on these documents
Alice S. Tsao (1)Demitria J. Xiradakis (1)Evan Tong (1)Syeda N. Mahazabin (1)
FEI number 2431929 · most recent document Oct 23, 2023
About Epic Pharmaz LLC
How many FDA Form 483s has Epic Pharmaz LLC received?
FDA Intel has 3 Form 483s on file for Epic Pharmaz LLC; the most recent is dated Oct 23, 2023.
When was Epic Pharmaz LLC last inspected by FDA?
The most recent FDA inspection document on file for Epic Pharmaz LLC is a Form 483 dated Oct 23, 2023, for the site in Laurelton, New York.
What did FDA cite at Epic Pharmaz LLC?
The regulations cited most in the observations on file for Epic Pharmaz LLC are 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 4 times; 21 CFR 211.67(a) (Equipment cleaning and maintenance), 2 times; 21 CFR 211.100(a) (Written procedures; deviations), 1 time.