Episciences, Inc.
Form 483 issued March 11, 2022 · Boise, Idaho
- Inspection
- Mar 7 – Mar 11, 2022
- Investigator
- Khoa Nathan V. Tran
- Observations
- 8
- Pages
- 8
- FEI number
- 3006435842
In short: On March 11, 2022, FDA issued a Form 483 with 8 observations to Episciences, Inc. in Boise, Idaho (FEI 3006435842) after an inspection that ran Mar 7 – Mar 11, 2022. The investigator was Khoa Nathan V. Tran. Most observations concern laboratory controls and materials; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and materials account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 02
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 03
There is a failure to thoroughly review the failure of a batch or any of its…
- 04
Control procedures are not established which validate the performance of those manufacturing processes that may be…
This inspection in context
Khoa Nathan V. Tran
21 documents · 2021–2026
Cites 211.84 (testing and approval or rejection of components, drug product containers, and closures) more than any other section. Most of their documents are for sites in California.
The firmEpisciences, Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Episciences, Inc.?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, materials and quality system. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Episciences, Inc.?
Khoa Nathan V. Tran is named on this Form 483, for the inspection of Mar 7 – Mar 11, 2022. Each investigator has a profile showing what they cite most.
When was Episciences, Inc. inspected by FDA?
The inspection ran Mar 7 – Mar 11, 2022, and the Form 483 is dated March 11, 2022.
How do I get the full Form 483 for Episciences, Inc.?
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.