Quality Chemical Laboratories
Form 483 issued November 20, 2024 · Wilmington, North Carolina
- Investigators
- Oluwasefunm Agbanigo· Saundrea A. Munroe
- Observations
- 2
- Pages
- 3
- FEI number
- 3002323490
In short: On November 20, 2024, FDA issued a Form 483 with 2 observations to Quality Chemical Laboratories in Wilmington, North Carolina (FEI 3002323490). The investigators were Oluwasefunm Agbanigo and Saundrea A. Munroe. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.63 (equipment design, size, and location).
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.63 (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
Manufacturer Written records of investigations into the failure of a batch or any of its components…
This inspection in context
Oluwasefunm Agbanigo
4 documents · 2023–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Texas.
The firmQuality Chemical Laboratories history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.63
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Quality Chemical Laboratories?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.63 (equipment design, size, and location). The opening words of each observation are shown on this page.
Who inspected Quality Chemical Laboratories?
Oluwasefunm Agbanigo and Saundrea A. Munroe are named on this Form 483. Each investigator has a profile showing what they cite most.
When was Quality Chemical Laboratories inspected by FDA?
This Form 483 is dated November 20, 2024.
How do I get the full Form 483 for Quality Chemical Laboratories?
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.