Diamond Wipes International Inc.
Form 483 issued March 3, 2022 · Bucyrus, Ohio
- Inspection
- Feb 16 – Mar 3, 2022
- Investigator
- Ucheabuchi C. Chudi-Nwankwor
- Observations
- 7
- Pages
- 8
- FEI number
- 1000069268
In short: On March 3, 2022, FDA issued a Form 483 with 7 observations to Diamond Wipes International Inc. in Bucyrus, Ohio (FEI 1000069268) after an inspection that ran Feb 16 – Mar 3, 2022. The investigator was Ucheabuchi C. Chudi-Nwankwor. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Production and laboratory controls account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Control procedures are not established which monitor the output and validate the performance of those manufacturing…
- 02
In-process materials are not tested for purity and approved or rejected by the quality control unit…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
- 04
Written production and process control procedures are not followed in the execution of production and process…
This inspection in context
Ucheabuchi C. Chudi-Nwankwor
22 documents · 2016–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Ohio.
The firmDiamond Wipes International Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.110(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Diamond Wipes International Inc.?
FDA listed 7 observations on this Form 483, mostly about production, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Diamond Wipes International Inc.?
Ucheabuchi C. Chudi-Nwankwor is named on this Form 483, for the inspection of Feb 16 – Mar 3, 2022. Each investigator has a profile showing what they cite most.
When was Diamond Wipes International Inc. inspected by FDA?
The inspection ran Feb 16 – Mar 3, 2022, and the Form 483 is dated March 3, 2022.
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.