Mikart, Inc.
Form 483 issued January 18, 2019 · Atlanta, Georgia
- Inspection
- Jan 14 – Jan 18, 2019
- Investigator
- Rachael L. Cook
- Observations
- 2
- Pages
- 3
- FEI number
- 1050658
In short: On January 18, 2019, FDA issued a Form 483 with 2 observations to Mikart, Inc. in Atlanta, Georgia (FEI 1050658) after an inspection that ran Jan 14 – Jan 18, 2019. The investigator was Rachael L. Cook. Most observations concern materials and quality system; the most-cited regulation is 21 CFR 211.82 (receipt and storage of untested components, drug product containers, and closures).
At a glance
Materials and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.82(b) (1×) · 211.25(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Incoming components are not stored under quarantine until they have been tested or examined…
- 02
GMP training is not conducted with sufficient frequency to assure that employees remain familiar with CGMP…
This inspection in context
Rachael L. Cook
8 documents · 2016–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Georgia.
The firmMikart, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.82(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Mikart, Inc.?
FDA listed 2 observations on this Form 483, mostly about materials and quality system. The most-cited regulation is 21 CFR 211.82 (receipt and storage of untested components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Mikart, Inc.?
Rachael L. Cook is named on this Form 483, for the inspection of Jan 14 – Jan 18, 2019. Each investigator has a profile showing what they cite most.
When was Mikart, Inc. inspected by FDA?
The inspection ran Jan 14 – Jan 18, 2019, and the Form 483 is dated January 18, 2019.
How do I get the full Form 483 for Mikart, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.