Cetylite Industries, Inc.
Form 483 issued December 20, 2019 · Pennsauken, New Jersey
- Inspection
- Dec 12 – Dec 20, 2019
- Investigator
- Russell J. Glapion
- Observations
- 2
- Pages
- 3
- FEI number
- 2242327
In short: On December 20, 2019, FDA issued a Form 483 with 2 observations to Cetylite Industries, Inc. in Pennsauken, New Jersey (FEI 2242327) after an inspection that ran Dec 12 – Dec 20, 2019. The investigator was Russell J. Glapion. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.25 (personnel qualifications).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.25 (1×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The number of qualified personnel is inadequate to perform and supervise the manufacture and processing…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
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 211.25
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 quality system and laboratory controls. The most-cited regulation is 21 CFR 211.25 (personnel qualifications). 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 Dec 12 – Dec 20, 2019. Each investigator has a profile showing what they cite most.
When was Cetylite Industries, Inc. inspected by FDA?
The inspection ran Dec 12 – Dec 20, 2019, and the Form 483 is dated December 20, 2019.
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.