Empower Clinic Services, LLC dba Empower

Form 483 issued November 3, 2025 · Houston, Texas

Inspection
Nov 3, 2025
Observations
6
Pages
5
FEI number
3021758709

In short: On November 3, 2025, FDA issued a Form 483 with 6 observations to Empower Clinic Services, LLC dba Empower in Houston, Texas (FEI 3021758709) after an inspection that ran Nov 3, 2025. The investigators were Camerson E. Moore and Oluwasefunm Agbanigo. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).

At a glance

5 of 6 observations on this 483 concern production.

Production5
Facilities & equipment1

Most cited: 21 CFR 211.113 (5×) · 211.67 (1×)

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

  1. 01

    Microbial contamination was present in…

  2. 02

    Failure to appropriately and regularly clean and disinfect or sterilize equipment located in…

  3. 03

    Products Personnel were observed conducting aseptic manipulations where the movement of "fir st air " in…

  4. 04

    Personnel were observed moving quickly in a critical area or in an area immediately adjacent to…

2 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

Questions about this 483

What did FDA find at Empower Clinic Services, LLC dba Empower?

FDA listed 6 observations on this Form 483, mostly about production and facilities & equipment. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.

Who inspected Empower Clinic Services, LLC dba Empower?

Camerson E. Moore and Oluwasefunm Agbanigo are named on this Form 483, for the inspection of Nov 3, 2025. Each investigator has a profile showing what they cite most.

When was Empower Clinic Services, LLC dba Empower inspected by FDA?

The inspection ran Nov 3, 2025, and the Form 483 is dated November 3, 2025.

How do I get the full Form 483 for Empower Clinic Services, LLC dba Empower?

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.

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