Epic Laboratories, LLC
Form 483 issued April 2, 2025 · Tampa, Florida
- Inspection
- Mar 25 – Apr 2, 2025
- Investigator
- Kayla V. Sprague
- Observations
- 7
- Pages
- 6
- FEI number
- 3010166225
In short: On April 2, 2025, FDA issued a Form 483 with 7 observations to Epic Laboratories, LLC in Tampa, Florida (FEI 3010166225) after an inspection that ran Mar 25 – Apr 2, 2025. The investigator was Kayla V. Sprague. Most observations concern production and quality system.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not…
- 02
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 03
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would…
- 04
The responsibilities and procedures applicable to the quality control unit are not in…
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 firmEpic Laboratories, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Epic Laboratories, LLC?
FDA listed 7 observations on this Form 483, mostly about production, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Epic Laboratories, LLC?
Kayla V. Sprague is named on this Form 483, for the inspection of Mar 25 – Apr 2, 2025. Each investigator has a profile showing what they cite most.
When was Epic Laboratories, LLC inspected by FDA?
The inspection ran Mar 25 – Apr 2, 2025, and the Form 483 is dated April 2, 2025.
How do I get the full Form 483 for Epic Laboratories, LLC?
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.