DERMARITE INDUSTRIES, LLC
Form 483 issued April 8, 2025 · NORTH BERGEN, New Jersey
- Inspection
- Mar 26 – Apr 8, 2025
- Investigator
- Annet R. Rajan
- Observations
- 6
- Pages
- 14
- FEI number
- 1000526900
In short: On April 8, 2025, FDA issued a Form 483 with 6 observations to DERMARITE INDUSTRIES, LLC in NORTH BERGEN, New Jersey (FEI 1000526900) after an inspection that ran Mar 26 – Apr 8, 2025. The investigator was Annet R. Rajan. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Annet R. Rajan
16 documents · 2020–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New Jersey.
The firmDERMARITE INDUSTRIES, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at DERMARITE INDUSTRIES, LLC?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, production and quality system. The opening words of each observation are shown on this page.
Who inspected DERMARITE INDUSTRIES, LLC?
Annet R. Rajan is named on this Form 483, for the inspection of Mar 26 – Apr 8, 2025. Each investigator has a profile showing what they cite most.
When was DERMARITE INDUSTRIES, LLC inspected by FDA?
The inspection ran Mar 26 – Apr 8, 2025, and the Form 483 is dated April 8, 2025.
How do I get the full Form 483 for DERMARITE INDUSTRIES, LLC?
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.