Eagle Labs Inc.
Form 483 issued December 6, 2023 · Seminole, Florida
- Inspection
- Nov 29 – Dec 6, 2023
- Investigator
- Kayla V. Sprague
- Observations
- 2
- Pages
- 3
- FEI number
- 3005552050
In short: On December 6, 2023, FDA issued a Form 483 with 2 observations to Eagle Labs Inc. in Seminole, Florida (FEI 3005552050) after an inspection that ran Nov 29 – Dec 6, 2023. The investigator was Kayla V. Sprague. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and production account for 2 of 2 observations.
Most cited: 21 CFR 211.67(b) (1×) · 211.100(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
- 02
Written production and process control procedures are not followed in the execution of production and process…
This inspection in context
Kayla V. Sprague
17 documents · 2020–2026
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Florida.
The firmEagle Labs Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Eagle Labs Inc.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and production. 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 Eagle Labs Inc.?
Kayla V. Sprague is named on this Form 483, for the inspection of Nov 29 – Dec 6, 2023. Each investigator has a profile showing what they cite most.
When was Eagle Labs Inc. inspected by FDA?
The inspection ran Nov 29 – Dec 6, 2023, and the Form 483 is dated December 6, 2023.
How do I get the full Form 483 for Eagle Labs 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.