Diamond Wipes International, Inc.
Form 483 issued March 19, 2021 · Chino, California
- Inspection
- Mar 8 – Mar 19, 2021
- Investigators
- Lisa Shin· Uttaniti Limchumroon
- Observations
- 6
- Pages
- 8
- FEI number
- 3003887639
In short: On March 19, 2021, FDA issued a Form 483 with 6 observations to Diamond Wipes International, Inc. in Chino, California (FEI 3003887639) after an inspection that ran Mar 8 – Mar 19, 2021. The investigators were Lisa Shin and Uttaniti Limchumroon. Most observations concern laboratory controls and facilities & equipment.
At a glance
Laboratory controls and facilities & equipment account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 02
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on…
This inspection in context
Lisa Shin
13 documents · 2020–2023
Cites 211.192 (production record review) 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 211.160(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Diamond Wipes International, Inc.?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Diamond Wipes International, Inc.?
Lisa Shin and Uttaniti Limchumroon are named on this Form 483, for the inspection of Mar 8 – Mar 19, 2021. Each investigator has a profile showing what they cite most.
When was Diamond Wipes International, Inc. inspected by FDA?
The inspection ran Mar 8 – Mar 19, 2021, and the Form 483 is dated March 19, 2021.
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.