Empower Clinic Services New Jersey, LLC
Form 483 issued November 18, 2024 · East Windsor, New Jersey
- Inspection
- Nov 8 – Nov 18, 2024
- Investigators
- Anthony Donato· Brandy N. Lepage
- Observations
- 7
- Pages
- 8
- FEI number
- 3033132864
In short: On November 18, 2024, FDA issued a Form 483 with 7 observations to Empower Clinic Services New Jersey, LLC in East Windsor, New Jersey (FEI 3033132864) after an inspection that ran Nov 8 – Nov 18, 2024. The investigators were Anthony Donato and Brandy N. Lepage. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and laboratory controls account for 5 of 7 observations.
Most cited: 21 CFR 211.22 (2×) · 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written procedures are not reviewed and approved by…
- 02
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Anthony Donato
6 documents · 2020–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in New Jersey.
The firmEmpower Clinic Services New Jersey, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Empower Clinic Services New Jersey, LLC?
FDA listed 7 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Empower Clinic Services New Jersey, LLC?
Anthony Donato and Brandy N. Lepage are named on this Form 483, for the inspection of Nov 8 – Nov 18, 2024. Each investigator has a profile showing what they cite most.
When was Empower Clinic Services New Jersey, LLC inspected by FDA?
The inspection ran Nov 8 – Nov 18, 2024, and the Form 483 is dated November 18, 2024.
How do I get the full Form 483 for Empower Clinic Services New Jersey, 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.