RX South DBA RX3 Compounding Pharmacy LLC
FDA inspection history in Chester, Virginia, 2012 to 2019
- 4
- Form 483s
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Close-out
- Form 483
- Warning letter
2012: two Form 483s; 2014: one warning letter and one Form 483; 2016: one Form 483; 2019: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2012–16Four Form 483s and one warning letter, at Chester, Virginia.
- 2012The longest 483 on file: 13 observations over 8 pages at Chester, Virginia.
- 2019One close-out letter, at Chester, Virginia.
Cited most
Across all RX South DBA RX3 Compounding Pharmacy observations on file
- 21 CFR 211.113Control of microbiological contamination9
- 21 CFR 211.42Design and construction features6
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures5
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.165Testing and release for distribution3
The complete RX South DBA RX3 Compounding Pharmacy file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Chester, Virginia
Four Form 483s, one close-out letter and one warning letter · 2012 to 2019 · 38 observations
Latest: Close-out, Jun 26, 2019 →
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-06-26 | Close-out Close-out letter | Chester, Virginia | — | $99 |
| 2016-05-06 | 483 Form 483 | Chester, Virginia | 6 | $99 |
| 2014-10-23 | Warning letter Warning letter | Chester, Virginia | — | $99 |
| 2014-02-21 | 483 Form 483 | Chester, Virginia | 11 | $99 |
| 2012-12-14 | 483 Form 483 | Chester, Virginia | 8 | $99 |
| 2012-12-14 | 483 Form 483 | Chester, Virginia | 13 | $99 |
Investigators on these documents
Rachel C. Harrington (2)Brooke K. Higgins (1)Haijing Hu (1)Linda F. Murphy (1)Stacie Woods (1)
FEI number 3008723337 · most recent document Jun 26, 2019
About RX South DBA RX3 Compounding Pharmacy LLC
How many FDA Form 483s has RX South DBA RX3 Compounding Pharmacy LLC received?
FDA Intel has 4 Form 483s on file for RX South DBA RX3 Compounding Pharmacy LLC; the most recent is dated May 6, 2016.
When was RX South DBA RX3 Compounding Pharmacy LLC last inspected by FDA?
The most recent FDA inspection document on file for RX South DBA RX3 Compounding Pharmacy LLC is a Form 483 dated May 6, 2016, for the site in Chester, Virginia.
What did FDA cite at RX South DBA RX3 Compounding Pharmacy LLC?
The regulations cited most in the observations on file for RX South DBA RX3 Compounding Pharmacy LLC are 21 CFR 211.113 (Control of microbiological contamination), 9 times; 21 CFR 211.42 (Design and construction features), 6 times; 21 CFR 211.84 (Testing and approval or rejection of components, drug product containers, and closures), 5 times.
Has RX South DBA RX3 Compounding Pharmacy LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for RX South DBA RX3 Compounding Pharmacy LLC; the most recent is dated Oct 23, 2014.