Stanley Specialty Pharmacy Compounding and Wellness Center
FDA inspection history in Charlotte, North Carolina, 2016 to 2022
- 3
- Form 483s
- 2
- Close-outs
Every document, by year
- Close-out
- Form 483
2016: one Form 483; 2017: one Form 483; 2018: one close-out letter; 2021: one Form 483; 2022: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–18Two Form 483s and one close-out letter, at Charlotte, North Carolina.
- 2016The longest 483 on file: 4 observations over 2 pages at Charlotte, North Carolina.
- 2021–22One Form 483 and one close-out letter, at Charlotte, North Carolina.
Cited most
Across all Stanley Specialty Pharmacy Compounding and Wellness Center observations on file
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.160General requirements1
- 21 CFR 211.28(a)Personnel responsibilities1
The complete Stanley Specialty Pharmacy Compounding and Wellness Center file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Charlotte, North Carolina
Three Form 483s and two close-out letters · 2016 to 2022 · 8 observations
Latest: Close-out, Feb 8, 2022 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-02-08 | Close-out Close-out letter | Charlotte, North Carolina | — | $99 |
| 2021-10-01 | 483 Form 483 | Charlotte, North Carolina | 1 | $99 |
| 2018-07-24 | Close-out Close-out letter | Charlotte, North Carolina | — | $99 |
| 2017-08-04 | 483 Form 483 | Charlotte, North Carolina | 3 | $99 |
| 2016-07-07 | 483 Form 483 | Charlotte, North Carolina | 4 | $99 |
Investigators on these documents
FEI number 3012184662 · most recent document Feb 8, 2022
About Stanley Specialty Pharmacy Compounding and Wellness Center
How many FDA Form 483s has Stanley Specialty Pharmacy Compounding and Wellness Center received?
FDA Intel has 3 Form 483s on file for Stanley Specialty Pharmacy Compounding and Wellness Center; the most recent is dated Oct 1, 2021.
When was Stanley Specialty Pharmacy Compounding and Wellness Center last inspected by FDA?
The most recent FDA inspection document on file for Stanley Specialty Pharmacy Compounding and Wellness Center is a Form 483 dated Oct 1, 2021, for the site in Charlotte, North Carolina.
What did FDA cite at Stanley Specialty Pharmacy Compounding and Wellness Center?
The regulations cited most in the observations on file for Stanley Specialty Pharmacy Compounding and Wellness Center are 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.42 (Design and construction features), 3 times; 21 CFR 211.160 (General requirements), 1 time.