Mikart, Inc.
FDA inspection history across 2 sites, 2002 to 2021
- 1
- Close-out
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Close-out
- Form 483
- Warning letter
2002: one warning letter; 2019: one Form 483; 2021: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2002One warning letter, at Atlanta, Georgia.
- 2019–21One Form 483 and one close-out letter, at Atlanta, Georgia and Cincinnatti, Ohio.
Cited most
Across all Mikart observations on file
- 21 CFR 211.25(a)Personnel qualifications1
- 21 CFR 211.82(b)Receipt and storage of untested components, drug product containers, and closures1
The complete Mikart file.
All 3 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
Atlanta, Georgia
One Form 483 and one warning letter · 2002 to 2019 · 2 observations
Latest: Form 483, Jan 18, 2019 →Cincinnatti, Ohio
One close-out letter · 2021
Latest: Close-out, Nov 17, 2021 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-11-17 | Close-out Close-out letter | Cincinnatti, Ohio | — | $99 |
| 2019-01-18 | 483 Form 483 | Atlanta, Georgia | 2 | $99 |
| 2002-10-11 | Warning letter Warning letter | Atlanta, Georgia | — | $99 |
Investigators on these documents
FEI number 1050658 · most recent document Nov 17, 2021
About Mikart, Inc.
How many FDA Form 483s has Mikart, Inc. received?
FDA Intel has 1 Form 483 on file for Mikart, Inc.; the most recent is dated Jan 18, 2019.
When was Mikart, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Mikart, Inc. is a Form 483 dated Jan 18, 2019, for the site in Atlanta, Georgia.
What did FDA cite at Mikart, Inc.?
The regulations cited most in the observations on file for Mikart, Inc. are 21 CFR 211.25(a) (Personnel qualifications), 1 time; 21 CFR 211.82(b) (Receipt and storage of untested components, drug product containers, and closures), 1 time.
Has Mikart, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Mikart, Inc.; the most recent is dated Oct 11, 2002.