Cetylite Industries, Inc.
Form 483 issued April 7, 2025 · Pennsauken, New Jersey
- Investigator
- Elizabeth A. Krolczyk
- Observations
- 2
- Pages
- 23
- FEI number
- 2242327
In short: On April 7, 2025, FDA issued a Form 483 with 2 observations to Cetylite Industries, Inc. in Pennsauken, New Jersey (FEI 2242327). The investigator was Elizabeth A. Krolczyk. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
2 of 2 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.70 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures to control environmental conditions…
- 02
Schedules for the adjustment, cleaning, and other maintenance of equipment have…
This inspection in context
Elizabeth A. Krolczyk
6 documents · 2024–2026
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in Texas.
The firmCetylite Industries, Inc. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.70
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cetylite Industries, Inc.?
FDA listed 2 observations on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.
Who inspected Cetylite Industries, Inc.?
Elizabeth A. Krolczyk is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Cetylite Industries, Inc. inspected by FDA?
This Form 483 is dated April 7, 2025.
How do I get the full Form 483 for Cetylite Industries, 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.