Diamond Wipes International, Inc.
Form 483 issued September 6, 2019 · Chino, California
- Inspection
- Sep 3 – Sep 6, 2019
- Investigators
- Marlo I. Alintanahin· Sonya L. Karsik
- Observations
- 2
- Pages
- 4
- FEI number
- 3003887639
In short: On September 6, 2019, FDA issued a Form 483 with 2 observations to Diamond Wipes International, Inc. in Chino, California (FEI 3003887639) after an inspection that ran Sep 3 – Sep 6, 2019. The investigators were Marlo I. Alintanahin and Sonya L. Karsik. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.50 (purchasing controls).
At a glance
Production & process controls and capa account for 2 of 2 observations.
Most cited: 21 CFR 820.50 (1×) · 803.17 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 02
Written MDR procedures have not been…
This inspection in context
Marlo I. Alintanahin
2 documents · 2019
Cites 803.17 (what are the requirements for developing, maintaining, and implementing written mdr procedures that apply to me?) more than any other section. Most of their documents are for sites in California.
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 820.50
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 production & process controls and cAPA. The most-cited regulation is 21 CFR 820.50 (purchasing controls). The opening words of each observation are shown on this page.
Who inspected Diamond Wipes International, Inc.?
Marlo I. Alintanahin and Sonya L. Karsik are named on this Form 483, for the inspection of Sep 3 – Sep 6, 2019. Each investigator has a profile showing what they cite most.
When was Diamond Wipes International, Inc. inspected by FDA?
The inspection ran Sep 3 – Sep 6, 2019, and the Form 483 is dated September 6, 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.