Oasis Advanced Wellness, LLC
Form 483 issued February 28, 2017 · The Woodlands, Texas
- Inspection
- Nov 17, 2016 – Feb 28, 2017
- Investigators
- Charles B. Steinmiller· Stephen D. Brown
- Observations
- 5
- Pages
- 6
- FEI number
- 3007577037
In short: On February 28, 2017, FDA issued a Form 483 with 5 observations to Oasis Advanced Wellness, LLC in The Woodlands, Texas (FEI 3007577037) after an inspection that ran Nov 17, 2016 – Feb 28, 2017. The investigators were Charles B. Steinmiller and Stephen D. Brown. Most observations concern dietary supplement CGMP.
At a glance
5 of 5 observations on this 483 concern dietary supplement cgmp.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 0121 CFR 111.65
Your quality control personnel did not ensure that your manufacturing, packaging, labeling and holding operations ensure…
- 02
You do not prepare a written master manufacturing record for each unique formulation of a…
- 03
You did not prepare a batch production record every' time you manufactured a…
- 04
You did not establish product specifications for identity, purity, strength and composition…
This inspection in context
Charles B. Steinmiller
5 documents · 2015–2024
Cites 110.35 (sanitary operations) more than any other section. Most of their documents are for sites in Texas.
The firmOasis Advanced Wellness, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 111.205
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Oasis Advanced Wellness, LLC?
FDA listed 5 observations on this Form 483, mostly about dietary supplement CGMP. The opening words of each observation are shown on this page.
Who inspected Oasis Advanced Wellness, LLC?
Charles B. Steinmiller and Stephen D. Brown are named on this Form 483, for the inspection of Nov 17, 2016 – Feb 28, 2017. Each investigator has a profile showing what they cite most.
When was Oasis Advanced Wellness, LLC inspected by FDA?
The inspection ran Nov 17, 2016 – Feb 28, 2017, and the Form 483 is dated February 28, 2017.
How do I get the full Form 483 for Oasis Advanced Wellness, 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.