Empower Clinic Services, LLC
Form 483 issued November 14, 2025 · Houston, Texas
- Inspection
- Nov 3 – Nov 14, 2025
- Investigators
- Joohi Castelvetere· Muna Algharibeh
- Observations
- 9
- Pages
- 19
- FEI number
- 3011887629
In short: On November 14, 2025, FDA issued a Form 483 with 9 observations to Empower Clinic Services, LLC in Houston, Texas (FEI 3011887629) after an inspection that ran Nov 3 – Nov 14, 2025. The investigators were Joohi Castelvetere and Muna Algharibeh. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Your fnm failed to establish an adequate system for cleaning and disinfecting the room and equipment…
This inspection in context
Joohi Castelvetere
9 documents · 2024–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Indiana.
The firmEmpower Clinic Services, LLC history
All 12 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Empower Clinic Services, LLC?
FDA listed 9 observations on this Form 483, mostly about production, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Empower Clinic Services, LLC?
Joohi Castelvetere and Muna Algharibeh are named on this Form 483, for the inspection of Nov 3 – Nov 14, 2025. Each investigator has a profile showing what they cite most.
When was Empower Clinic Services, LLC inspected by FDA?
The inspection ran Nov 3 – Nov 14, 2025, and the Form 483 is dated November 14, 2025.
How do I get the full Form 483 for Empower Clinic Services, 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.