Episciences, Inc.
Form 483 issued January 29, 2024 · Boise, Idaho
- Inspection
- Jan 22 – Jan 29, 2024
- Investigator
- Bryan L. McGuckin
- Observations
- 5
- Pages
- 5
- FEI number
- 3006435842
In short: On January 29, 2024, FDA issued a Form 483 with 5 observations to Episciences, Inc. in Boise, Idaho (FEI 3006435842) after an inspection that ran Jan 22 – Jan 29, 2024. The investigator was Bryan L. McGuckin. Most observations concern laboratory controls and facilities & equipment.
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
There is no written testing program designed to assess the stability…
- 02
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods…
- 03
Each lot of components is not withheld from use until the lot has been sampled, tested…
- 04
Access to the storage area for labels and labeling materials is not…
This inspection in context
Bryan L. McGuckin
30 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.
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 211.166(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Episciences, Inc.?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected Episciences, Inc.?
Bryan L. McGuckin is named on this Form 483, for the inspection of Jan 22 – Jan 29, 2024. Each investigator has a profile showing what they cite most.
When was Episciences, Inc. inspected by FDA?
The inspection ran Jan 22 – Jan 29, 2024, and the Form 483 is dated January 29, 2024.
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.