Oasis Advanced Wellness, LLC

FDA inspection history in The Woodlands, Texas, 2017

1
Form 483

Every document, by year

  • Form 483

2017: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2017One Form 483, at The Woodlands, Texas.

Cited most

Across all Oasis Advanced Wellness observations on file

  • 21 CFR 111.205
    What is the requirement to establish a master manufacturing record?
    1
  • 21 CFR 111.255
    What is the requirement to establish a batch production record?
    1
  • 21 CFR 111.65
    What are the requirements for quality control operations?
    1
  • 21 CFR 111.70
    What specifications must you establish?
    1
  • 21 CFR 111.83
    What are the requirements for reserve samples?
    1

The complete Oasis Advanced Wellness file.

All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.

$99

The documents one by one, while the file is prepared

See the documents

Sites

Documents

1 on file, newest first
DateDocumentPrice
2017-02-28483 Form 483$99

Investigators on these documents

Charles B. Steinmiller (1)Stephen D. Brown (1)

FEI number 3007577037 · most recent document Feb 28, 2017

About Oasis Advanced Wellness, LLC

How many FDA Form 483s has Oasis Advanced Wellness, LLC received?

FDA Intel has 1 Form 483 on file for Oasis Advanced Wellness, LLC; the most recent is dated Feb 28, 2017.

When was Oasis Advanced Wellness, LLC last inspected by FDA?

The most recent FDA inspection document on file for Oasis Advanced Wellness, LLC is a Form 483 dated Feb 28, 2017, for the site in The Woodlands, Texas.

What did FDA cite at Oasis Advanced Wellness, LLC?

The regulations cited most in the observations on file for Oasis Advanced Wellness, LLC are 21 CFR 111.205 (What is the requirement to establish a master manufacturing record?), 1 time; 21 CFR 111.255 (What is the requirement to establish a batch production record?), 1 time; 21 CFR 111.65 (What are the requirements for quality control operations?), 1 time.