Diversified Chemical Products
Form 483 issued January 31, 2025 · Wilmington, Delaware
- Observations
- 2
- Pages
- 28
- FEI number
- 1000071265
In short: On January 31, 2025, FDA issued a Form 483 with 2 observations to Diversified Chemical Products in Wilmington, Delaware (FEI 1000071265). The investigators were Christian F. Gomez Lugo, Marian E. Ramirez and Yoriann M. Cabrera Bartolomei. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×) · 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Christian F. Gomez Lugo
6 documents · 2024–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in North Carolina.
The firmDiversified Chemical Products history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Diversified Chemical Products?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Diversified Chemical Products?
Christian F. Gomez Lugo, Marian E. Ramirez and Yoriann M. Cabrera Bartolomei are named on this Form 483. Each investigator has a profile showing what they cite most.
When was Diversified Chemical Products inspected by FDA?
This Form 483 is dated January 31, 2025.
How do I get the full Form 483 for Diversified Chemical Products?
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.