Purac America, Inc.
FDA inspection history across 2 sites, 2001 to 2024
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2001: one warning letter; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2001One warning letter, at Lincolnshire, Illinois.
- 2024One Form 483, at Tucker, Georgia.
Cited most
Across all Purac America observations on file
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.28Personnel responsibilities1
- 21 CFR 211.42Design and construction features1
- 21 CFR 211.67Equipment cleaning and maintenance1
The complete Purac America 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
Tucker, Georgia
One Form 483 · 2024 · 5 observations
Latest: Form 483, Aug 2, 2024 →Lincolnshire, Illinois
One warning letter · 2001
Latest: Warning letter, Oct 23, 2001 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-08-02 | 483 Form 483 | Tucker, Georgia | 5 | $99 |
| 2001-10-23 | Warning letter Warning letter | Lincolnshire, Illinois | — | $99 |
FEI number 3016432787 · most recent document Aug 2, 2024
About Purac America, Inc.
How many FDA Form 483s has Purac America, Inc. received?
FDA Intel has 1 Form 483 on file for Purac America, Inc.; the most recent is dated Aug 2, 2024.
When was Purac America, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Purac America, Inc. is a Form 483 dated Aug 2, 2024, for the site in Tucker, Georgia.
What did FDA cite at Purac America, Inc.?
The regulations cited most in the observations on file for Purac America, Inc. are 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 2 times; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time; 21 CFR 211.28 (Personnel responsibilities), 1 time.
Has Purac America, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Purac America, Inc.; the most recent is dated Oct 23, 2001.