Tulex Pharmaceuticals Inc.

FDA inspection history in Cranbury, New Jersey, 2019 to 2025

2
Form 483s

Every document, by year

  • Form 483

2019: one Form 483; 2025: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2019One Form 483, at Cranbury, New Jersey.
  2. 2025One Form 483, at Cranbury, New Jersey.
  3. 2025The longest 483 on file: 2 observations over 4 pages at Cranbury, New Jersey.

Cited most

Across all Tulex Pharmaceuticals observations on file

The complete Tulex Pharmaceuticals file.

All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.

$198

The price of the documents, added to your cart together

Sites

Documents

2 on file, newest first
DateDocumentPrice
2025-03-24483 Form 483$99
2019-12-12483 Form 483$99

Investigators on these documents

James R. Birkenstamm (1)Suchan Kim (1)

FEI number 3011875665 · most recent document Mar 24, 2025

About Tulex Pharmaceuticals Inc.

How many FDA Form 483s has Tulex Pharmaceuticals Inc. received?

FDA Intel has 2 Form 483s on file for Tulex Pharmaceuticals Inc.; the most recent is dated Mar 24, 2025.

When was Tulex Pharmaceuticals Inc. last inspected by FDA?

The most recent FDA inspection document on file for Tulex Pharmaceuticals Inc. is a Form 483 dated Mar 24, 2025, for the site in Cranbury, New Jersey.

What did FDA cite at Tulex Pharmaceuticals Inc.?

The regulations cited most in the observations on file for Tulex Pharmaceuticals Inc. are 21 CFR 211.160(b) (General requirements), 1 time; 21 CFR 211.192 (Production record review), 1 time.