People's Custom Rx and Clinical Care, LLC
FDA inspection history across 2 sites, 2015 to 2021
- 5
- Form 483s
- 2
- Responses
- 1
- Warning letter
Every document, by year
- Response
- Form 483
- Warning letter
2015: one 483 response and one Form 483; 2016: one warning letter; 2018: two Form 483s; 2019: one Form 483; 2021: one 483 response and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–21Five Form 483s, two 483 responses and one warning letter, at Memphis, Tennessee and Tennessee.
- 2015The longest 483 on file: 9 observations over 5 pages at Memphis, Tennessee.
Cited most
Across all People's Custom Rx and Clinical Care observations on file
- 21 CFR 211.113Control of microbiological contamination10
- 21 CFR 211.42Design and construction features5
- 21 CFR 211.56Sanitation3
- 21 CFR 211.165Testing and release for distribution2
- 21 CFR 211.167Special testing requirements2
The complete People's Custom Rx and Clinical Care file.
All 8 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Memphis, Tennessee
Five Form 483s, one warning letter and one 483 response · 2015 to 2021 · 26 observations
Latest: Form 483, Aug 5, 2021 →Tennessee
One 483 response · 2021
Latest: Response, Aug 23, 2021 →
Documents
8 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-08-23 | Response 483 response | Tennessee | — | $199 |
| 2021-08-05 | 483 Form 483 | Memphis, Tennessee | 3 | $99 |
| 2019-07-24 | 483 Form 483 | Memphis, Tennessee | 4 | $99 |
| 2018-07-19 | 483 Form 483 | Memphis, Tennessee | 5 | $99 |
| 2018-06-25 | 483 Form 483 | Memphis, Tennessee | 5 | $99 |
| 2016-06-06 | Warning letter Warning letter | Memphis, Tennessee | — | $99 |
| 2015-08-13 | Response 483 response | Memphis, Tennessee | — | $199 |
| 2015-07-29 | 483 Form 483 | Memphis, Tennessee | 9 | $99 |
Investigators on these documents
Stephen D. Brown (3)Mary A. Millner (2)Zada L. Giles (2)Clinton J. Lott (1)Marvin D. Jones (1)
FEI number 3003780900 · most recent document Aug 23, 2021
About People's Custom Rx and Clinical Care, LLC
How many FDA Form 483s has People's Custom Rx and Clinical Care, LLC received?
FDA Intel has 5 Form 483s on file for People's Custom Rx and Clinical Care, LLC; the most recent is dated Aug 5, 2021.
When was People's Custom Rx and Clinical Care, LLC last inspected by FDA?
The most recent FDA inspection document on file for People's Custom Rx and Clinical Care, LLC is a Form 483 dated Aug 5, 2021, for the site in Memphis, Tennessee.
What did FDA cite at People's Custom Rx and Clinical Care, LLC?
The regulations cited most in the observations on file for People's Custom Rx and Clinical Care, LLC are 21 CFR 211.113 (Control of microbiological contamination), 10 times; 21 CFR 211.42 (Design and construction features), 5 times; 21 CFR 211.56 (Sanitation), 3 times.
Has People's Custom Rx and Clinical Care, LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for People's Custom Rx and Clinical Care, LLC; the most recent is dated Jun 6, 2016.