Cetylite Industries, Inc.
Form 483 issued September 24, 2021 · Pennsauken, New Jersey
- Inspection
- Sep 20 – Sep 24, 2021
- Investigator
- Russell J. Glapion
- Observations
- 2
- Pages
- 3
- FEI number
- 2242327
In short: On September 24, 2021, FDA issued a Form 483 with 2 observations to Cetylite Industries, Inc. in Pennsauken, New Jersey (FEI 2242327) after an inspection that ran Sep 20 – Sep 24, 2021. The investigator was Russell J. Glapion. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.160(b) (1×) · 211.192 (1×)
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 standards designed…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Russell J. Glapion
18 documents · 2013–2021
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in New Jersey.
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 211.160(b)
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 laboratory controls and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Cetylite Industries, Inc.?
Russell J. Glapion is named on this Form 483, for the inspection of Sep 20 – Sep 24, 2021. Each investigator has a profile showing what they cite most.
When was Cetylite Industries, Inc. inspected by FDA?
The inspection ran Sep 20 – Sep 24, 2021, and the Form 483 is dated September 24, 2021.
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.