Cetylite Industries, Inc.
Form 483 issued December 9, 2024 · Pennsauken, New Jersey
- Inspection
- Nov 14 – Dec 9, 2024
- Investigators
- Juanita P. Versace· Rahi D. Patel
- Observations
- 4
- Pages
- 7
- FEI number
- 2242327
In short: On December 9, 2024, FDA issued a Form 483 with 4 observations to Cetylite Industries, Inc. in Pennsauken, New Jersey (FEI 2242327) after an inspection that ran Nov 14 – Dec 9, 2024. The investigators were Juanita P. Versace and Rahi D. Patel. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Your firm failed to establish written procedures for production and process controls designed to assure that…
- 02
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 04
Procedures designed to prevent objectionable microorganisms in ding products not required to be…
This inspection in context
Juanita P. Versace
9 documents · 2009–2024
Cites 211.113 (control of microbiological contamination) 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 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cetylite Industries, Inc.?
FDA listed 4 observations on this Form 483, mostly about production, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Cetylite Industries, Inc.?
Juanita P. Versace and Rahi D. Patel are named on this Form 483, for the inspection of Nov 14 – Dec 9, 2024. Each investigator has a profile showing what they cite most.
When was Cetylite Industries, Inc. inspected by FDA?
The inspection ran Nov 14 – Dec 9, 2024, and the Form 483 is dated December 9, 2024.
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.