The Wellness Pharmacy, LLC
FDA inspection history across 3 sites, 2015 to 2018
- 2
- Warning letters
- 2
- Form 483s
- 1
- Response
Every document, by year
- Warning letter
- Form 483
- Response
2015: one 483 response and one Form 483; 2016: one warning letter; 2017: one Form 483; 2018: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–18Two Form 483s, two warning letters and one 483 response, at Winchester, Virginia; Winchester, California and Virginia.
- 2015The longest 483 on file: 4 observations over 4 pages at Winchester, California.
Cited most
Across all The Wellness Pharmacy observations on file
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.167(a)Special testing requirements1
- 21 CFR 211.42(c)Design and construction features1
- 21 CFR 211.63Equipment design, size, and location1
- 21 CFR 211.65Equipment construction1
The complete The Wellness Pharmacy file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Winchester, Virginia
One Form 483, one warning letter and one 483 response · 2015 to 2017 · 2 observations
Latest: Form 483, May 16, 2017 →Virginia
One warning letter · 2018
Latest: Warning letter, Jan 24, 2018 →Winchester, California
One Form 483 · 2015 · 4 observations
Latest: Form 483, Mar 12, 2015 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-01-24 | Warning letter Warning letter | Virginia | — | $99 |
| 2017-05-16 | 483 Form 483 | Winchester, Virginia | 2 | $99 |
| 2016-03-23 | Warning letter Warning letter | Winchester, Virginia | — | $99 |
| 2015-03-16 | Response 483 response | Winchester, Virginia | — | $199 |
| 2015-03-12 | 483 Form 483 | Winchester, California | 4 | $99 |
Investigators on these documents
FEI number 3011402879 · most recent document Jan 24, 2018
About The Wellness Pharmacy, LLC
How many FDA Form 483s has The Wellness Pharmacy, LLC received?
FDA Intel has 2 Form 483s on file for The Wellness Pharmacy, LLC; the most recent is dated May 16, 2017.
When was The Wellness Pharmacy, LLC last inspected by FDA?
The most recent FDA inspection document on file for The Wellness Pharmacy, LLC is a Form 483 dated May 16, 2017, for the site in Winchester, Virginia.
What did FDA cite at The Wellness Pharmacy, LLC?
The regulations cited most in the observations on file for The Wellness Pharmacy, LLC are 21 CFR 211.113(b) (Control of microbiological contamination), 1 time; 21 CFR 211.167(a) (Special testing requirements), 1 time; 21 CFR 211.42(c) (Design and construction features), 1 time.
Has The Wellness Pharmacy, LLC received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for The Wellness Pharmacy, LLC; the most recent is dated Jan 24, 2018.