Apex International Mfg., LLC
Form 483 issued January 27, 2015 · Chaska, Minnesota
- Inspection
- Jan 13 – Jan 27, 2015
- Investigator
- April L. Young
- Observations
- 1
- Pages
- 1
- FEI number
- 2130334
In short: On January 27, 2015, FDA issued a Form 483 with 1 observation to Apex International Mfg., LLC in Chaska, Minnesota (FEI 2130334) after an inspection that ran Jan 13 – Jan 27, 2015. The investigator was April L. Young. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
This inspection in context
April L. Young
5 documents · 2014–2015
Cites 211.110 (sampling and testing of in-process materials and drug products) more than any other section. Most of their documents are for sites in Minnesota.
The firmApex International Mfg., LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Apex International Mfg., LLC?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Apex International Mfg., LLC?
April L. Young is named on this Form 483, for the inspection of Jan 13 – Jan 27, 2015. Each investigator has a profile showing what they cite most.
When was Apex International Mfg., LLC inspected by FDA?
The inspection ran Jan 13 – Jan 27, 2015, and the Form 483 is dated January 27, 2015.
How do I get the full Form 483 for Apex International Mfg., LLC?
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.