Topiderm, Inc.
Form 483 issued March 7, 2025 · North Amityville, New York
- Inspection
- Feb 18 – Mar 7, 2025
- Investigator
- Khoa Nathan V. Tran
- Observations
- 8
- Pages
- 26
- FEI number
- 2432734
In short: On March 7, 2025, FDA issued a Form 483 with 8 observations to Topiderm, Inc. in North Amityville, New York (FEI 2432734) after an inspection that ran Feb 18 – Mar 7, 2025. The investigator was Khoa Nathan V. Tran. Most observations concern materials and production; the most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures).
At a glance
Materials and production account for 5 of 8 observations.
Most cited: 21 CFR 211.84 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Drug product component testing is deficient in that at least one specific test to verify the…
- 02
Component testing is deficient in that each component is not tested for conformity with all appropriate…
- 03
Establishment of the reliability of the component supplier's report of analyses is deficient in that the…
- 04
Your firm failed to establish written procedures for production and process controls designed to assure that…
This inspection in context
Khoa Nathan V. Tran
21 documents · 2021–2026
Cites 211.84 (testing and approval or rejection of components, drug product containers, and closures) more than any other section. Most of their documents are for sites in California.
The firmTopiderm, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.84
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Topiderm, Inc.?
FDA listed 8 observations on this Form 483, mostly about materials, production and laboratory controls. The most-cited regulation is 21 CFR 211.84 (testing and approval or rejection of components, drug product containers, and closures). The opening words of each observation are shown on this page.
Who inspected Topiderm, Inc.?
Khoa Nathan V. Tran is named on this Form 483, for the inspection of Feb 18 – Mar 7, 2025. Each investigator has a profile showing what they cite most.
When was Topiderm, Inc. inspected by FDA?
The inspection ran Feb 18 – Mar 7, 2025, and the Form 483 is dated March 7, 2025.
How do I get the full Form 483 for Topiderm, 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.