Episciences, Inc.
FDA inspection history in Boise, Idaho, 2015 to 2024
- 2
- Form 483s
- 2
- Warning letters
Every document, by year
- Form 483
- Warning letter
2015: one warning letter; 2022: one warning letter and one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One warning letter, at Boise, Idaho.
- 2022–24Two Form 483s and one warning letter, at Boise, Idaho.
- 2022The longest 483 on file: 8 observations over 8 pages at Boise, Idaho.
Cited most
Across all Episciences observations on file
- 21 CFR 211.165(a)Testing and release for distribution3
- 21 CFR 211.84(a)Testing and approval or rejection of components, drug product containers, and closures3
- 21 CFR 211.67(b)(3)Equipment cleaning and maintenance2
- 21 CFR 211.105(b)Equipment identification1
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
The complete Episciences file.
All 4 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
Boise, Idaho
Two Form 483s and two warning letters · 2015 to 2024 · 13 observations
Latest: Form 483, Jan 29, 2024 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-01-29 | 483 Form 483 | Boise, Idaho | 5 | $99 |
| 2022-08-25 | Warning letter Warning letter | Boise, Idaho | — | $99 |
| 2022-03-11 | 483 Form 483 | Boise, Idaho | 8 | $99 |
| 2015-12-02 | Warning letter Warning letter | Boise, Idaho | — | $99 |
Investigators on these documents
FEI number 3006435842 · most recent document Jan 29, 2024
About Episciences, Inc.
How many FDA Form 483s has Episciences, Inc. received?
FDA Intel has 2 Form 483s on file for Episciences, Inc.; the most recent is dated Jan 29, 2024.
When was Episciences, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Episciences, Inc. is a Form 483 dated Jan 29, 2024, for the site in Boise, Idaho.
What did FDA cite at Episciences, Inc.?
The regulations cited most in the observations on file for Episciences, Inc. are 21 CFR 211.165(a) (Testing and release for distribution), 3 times; 21 CFR 211.84(a) (Testing and approval or rejection of components, drug product containers, and closures), 3 times; 21 CFR 211.67(b)(3) (Equipment cleaning and maintenance), 2 times.
Has Episciences, Inc. received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Episciences, Inc.; the most recent is dated Aug 25, 2022.