Purechempros LLC
FDA inspection history in Tempe, Arizona, 2022 to 2023
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2022: one Form 483; 2023: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2022–23One Form 483 and one warning letter, at Tempe, Arizona.
Cited most
Across all Purechempros observations on file
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.186(a)Master production and control records1
- 21 CFR 211.22(a)Responsibilities of quality control unit1
The complete Purechempros file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Tempe, Arizona
One warning letter and one Form 483 · 2022 to 2023 · 7 observations
Latest: Warning letter, Sep 1, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-09-01 | Warning letter Warning letter | Tempe, Arizona | — | $99 |
| 2022-11-22 | 483 Form 483 | Tempe, Arizona | 7 | $99 |
Investigators on these documents
FEI number 3019411371 · most recent document Sep 1, 2023
About Purechempros LLC
How many FDA Form 483s has Purechempros LLC received?
FDA Intel has 1 Form 483 on file for Purechempros LLC; the most recent is dated Nov 22, 2022.
When was Purechempros LLC last inspected by FDA?
The most recent FDA inspection document on file for Purechempros LLC is a Form 483 dated Nov 22, 2022, for the site in Tempe, Arizona.
What did FDA cite at Purechempros LLC?
The regulations cited most in the observations on file for Purechempros LLC are 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.160(b) (General requirements), 1 time; 21 CFR 211.166(a) (Stability testing), 1 time.
Has Purechempros LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Purechempros LLC; the most recent is dated Sep 1, 2023.