Tulex Pharmaceuticals Inc.
Form 483 issued March 24, 2025 · Cranbury, New Jersey
- Inspection
- Mar 24, 2025
- Investigators
- James R. Birkenstamm· Suchan Kim
- Observations
- 2
- Pages
- 4
- FEI number
- 3011875665
In short: On March 24, 2025, FDA issued a Form 483 with 2 observations to Tulex Pharmaceuticals Inc. in Cranbury, New Jersey (FEI 3011875665) after an inspection that ran Mar 24, 2025. The investigators were James R. Birkenstamm and Suchan Kim. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.160(b) (1×)
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
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test…
This inspection in context
James R. Birkenstamm
12 documents · 2018–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in New Jersey.
The firmTulex Pharmaceuticals Inc. history
All 2 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 Tulex Pharmaceuticals Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Tulex Pharmaceuticals Inc.?
James R. Birkenstamm and Suchan Kim are named on this Form 483, for the inspection of Mar 24, 2025. Each investigator has a profile showing what they cite most.
When was Tulex Pharmaceuticals Inc. inspected by FDA?
The inspection ran Mar 24, 2025, and the Form 483 is dated March 24, 2025.
How do I get the full Form 483 for Tulex Pharmaceuticals 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.