The Wellness Center Pharmacy, Inc., dba Designer Drugs
FDA inspection history across 2 sites, 2015 to 2019
- 2
- Responses
- 2
- Form 483s
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Close-out
- Response
- Form 483
- Warning letter
2015: one Form 483; 2016: one warning letter; 2017: one Form 483; 2018: two 483 responses; 2019: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–19Two Form 483s, two 483 responses, one warning letter and one close-out letter, at Chattanooga, Tennessee and Tennessee.
- 2015The longest 483 on file: 13 observations over 6 pages at Chattanooga, Tennessee.
Cited most
Across all The Wellness Center Pharmacy, Inc., dba Designer Drugs observations on file
- 21 CFR 211.42(c)(10)(iii)Design and construction features3
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.165(a)Testing and release for distribution2
- 21 CFR 211.160(b)(4)General requirements1
- 21 CFR 211.166(a)Stability testing1
The complete The Wellness Center Pharmacy, Inc., dba Designer Drugs file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Chattanooga, Tennessee
Two Form 483s, one close-out letter and one warning letter · 2015 to 2019 · 16 observations
Latest: Close-out, Feb 6, 2019 →Tennessee
Two 483 responses · 2018
Latest: Response, Feb 9, 2018 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-02-06 | Close-out Close-out letter | Chattanooga, Tennessee | — | $99 |
| 2018-02-09 | Response 483 response | Tennessee | — | $199 |
| 2018-02-02 | Response 483 response | Tennessee | — | $199 |
| 2017-12-22 | 483 Form 483 | Chattanooga, Tennessee | 3 | $99 |
| 2016-08-05 | Warning letter Warning letter | Chattanooga, Tennessee | — | $99 |
| 2015-05-28 | 483 Form 483 | Chattanooga, Tennessee | 13 | $99 |
Investigators on these documents
Brandon C. Heitmeier (1)Brian J. Hettler (1)Luis A. Tovar (1)
FEI number 3004578635 · most recent document Feb 6, 2019
About The Wellness Center Pharmacy, Inc., dba Designer Drugs
How many FDA Form 483s has The Wellness Center Pharmacy, Inc., dba Designer Drugs received?
FDA Intel has 2 Form 483s on file for The Wellness Center Pharmacy, Inc., dba Designer Drugs; the most recent is dated Dec 22, 2017.
When was The Wellness Center Pharmacy, Inc., dba Designer Drugs last inspected by FDA?
The most recent FDA inspection document on file for The Wellness Center Pharmacy, Inc., dba Designer Drugs is a Form 483 dated Dec 22, 2017, for the site in Chattanooga, Tennessee.
What did FDA cite at The Wellness Center Pharmacy, Inc., dba Designer Drugs?
The regulations cited most in the observations on file for The Wellness Center Pharmacy, Inc., dba Designer Drugs are 21 CFR 211.42(c)(10)(iii) (Design and construction features), 3 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.165(a) (Testing and release for distribution), 2 times.
Has The Wellness Center Pharmacy, Inc., dba Designer Drugs received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for The Wellness Center Pharmacy, Inc., dba Designer Drugs; the most recent is dated Aug 5, 2016.