Cetylite Industries, Inc.
Form 483 issued March 2, 2023 · Pennsauken, New Jersey
- Inspection
- Feb 13 – Mar 2, 2023
- Investigator
- Syeda N. Mahazabin
- Observations
- 5
- Pages
- 9
- FEI number
- 2242327
In short: On March 2, 2023, FDA issued a Form 483 with 5 observations to Cetylite Industries, Inc. in Pennsauken, New Jersey (FEI 2242327) after an inspection that ran Feb 13 – Mar 2, 2023. The investigator was Syeda N. Mahazabin. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Each batch of drug product required to be free of objectionable microorganisms is not tested…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans…
- 04
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that…
This inspection in context
Syeda N. Mahazabin
19 documents · 2006–2026
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in New York.
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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cetylite Industries, Inc.?
FDA listed 5 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Cetylite Industries, Inc.?
Syeda N. Mahazabin is named on this Form 483, for the inspection of Feb 13 – Mar 2, 2023. Each investigator has a profile showing what they cite most.
When was Cetylite Industries, Inc. inspected by FDA?
The inspection ran Feb 13 – Mar 2, 2023, and the Form 483 is dated March 2, 2023.
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.