Form 483 · FEI 3004086743
Form 483 issued August 14, 2025 · Pittsburgh, Pennsylvania
- Inspection
- Aug 11 – Aug 14, 2025
- Investigator
- Yaharn Su
- Observations
- 3
- Pages
- 4
- FEI number
- 3004086743
In short: On August 14, 2025, FDA issued a Form 483 with 3 observations to an FDA-inspected site in Pittsburgh, Pennsylvania (FEI 3004086743) after an inspection that ran Aug 11 – Aug 14, 2025. The investigator was Yaharn Su. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 2 of 3 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
Drug products do not bear an expiration date determined by appropriate stability data to assure they…
This inspection in context
Yaharn Su
9 documents · 2023–2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Maryland.
The firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67(b)(3)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment, quality system and packaging & labeling. The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Yaharn Su is named on this Form 483, for the inspection of Aug 11 – Aug 14, 2025. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Aug 11 – Aug 14, 2025, and the Form 483 is dated August 14, 2025.
How do I get the full Form 483 for an FDA-inspected site?
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.