Pure Source, LLC
FDA inspection history in Doral, Florida, 2018 to 2023
- 3
- Form 483s
- 2
- Close-outs
Every document, by year
- Form 483
- Close-out
2018: one Form 483; 2019: two close-out letters and one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–19Two Form 483s and two close-out letters, at Doral, Florida.
- 2019The longest 483 on file: 3 observations over 4 pages at Doral, Florida.
- 2023One Form 483, at Doral, Florida.
Cited most
Across all Pure Source observations on file
- 21 CFR 211.100(b)Written procedures; deviations1
- 21 CFR 211.192Production record review1
- 21 CFR 211.63Equipment design, size, and location1
- 21 CFR 211.84(d)(2)Testing and approval or rejection of components, drug product containers, and closures1
- 21 CFR 820.40Document controls1
The complete Pure Source file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Doral, Florida
Three Form 483s and two close-out letters · 2018 to 2023 · 5 observations
Latest: Form 483, Aug 31, 2023 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-08-31 | 483 Form 483 | Doral, Florida | 1 | $99 |
| 2019-11-15 | Close-out Close-out letter | Doral, Florida | — | $99 |
| 2019-08-14 | 483 Form 483 | Doral, Florida | 3 | $99 |
| 2019-02-20 | Close-out Close-out letter | Doral, Florida | — | $99 |
| 2018-03-01 | 483 Form 483 | Doral, Florida | 1 | $99 |
Investigators on these documents
FEI number 3002754162 · most recent document Aug 31, 2023
About Pure Source, LLC
How many FDA Form 483s has Pure Source, LLC received?
FDA Intel has 3 Form 483s on file for Pure Source, LLC; the most recent is dated Aug 31, 2023.
When was Pure Source, LLC last inspected by FDA?
The most recent FDA inspection document on file for Pure Source, LLC is a Form 483 dated Aug 31, 2023, for the site in Doral, Florida.
What did FDA cite at Pure Source, LLC?
The regulations cited most in the observations on file for Pure Source, LLC are 21 CFR 211.100(b) (Written procedures; deviations), 1 time; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.63 (Equipment design, size, and location), 1 time.