Diamond Wipes International, Inc.
Form 483 issued April 19, 2019 · Chino, California
- Inspection
- Apr 15 – Apr 19, 2019
- Investigators
- Nicholas L. Hunt· Santiago Gallardo Johnson
- Observations
- 2
- Pages
- 2
- FEI number
- 3003887639
In short: On April 19, 2019, FDA issued a Form 483 with 2 observations to Diamond Wipes International, Inc. in Chino, California (FEI 3003887639) after an inspection that ran Apr 15 – Apr 19, 2019. The investigators were Nicholas L. Hunt and Santiago Gallardo Johnson. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.165 (testing and release for distribution).
At a glance
Laboratory controls and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.165(f) (1×) · 211.67(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Observation 1: scanned text, readable in the full document.
- 02
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
This inspection in context
Nicholas L. Hunt
38 documents · 2017–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Arizona.
The firmDiamond Wipes International, Inc. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165(f)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Diamond Wipes International, Inc.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.165 (testing and release for distribution). The opening words of each observation are shown on this page.
Who inspected Diamond Wipes International, Inc.?
Nicholas L. Hunt and Santiago Gallardo Johnson are named on this Form 483, for the inspection of Apr 15 – Apr 19, 2019. Each investigator has a profile showing what they cite most.
When was Diamond Wipes International, Inc. inspected by FDA?
The inspection ran Apr 15 – Apr 19, 2019, and the Form 483 is dated April 19, 2019.
How do I get the full Form 483 for Diamond Wipes International, 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.