In short: On April 7, 2026, FDA issued a Form 483 with 4 observations to ChemPacific Corporation in Baltimore, Maryland (FEI 3003299802) after an inspection that ran Mar 30 – Apr 3, 2026. The investigators were As Avrdes and Yaharn Su.
What FDA observed
Preview: the opening words of each observation- 01
The firm failed to maintain adequate quality control systems, including data integrity…
- 02
The firm failed to have an ongoing testing program designed to monitor the stability characteristics…
- 03
Materials are not handled and stored in a manner to prevent contamination and ensure proper identification…
- 04
Buildings used in the manufacture, processing, packing, or holding of intermediates and API are not maintained…
This inspection in context
Questions about this 483
What did FDA find at ChemPacific Corporation?
FDA listed 4 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected ChemPacific Corporation?
As Avrdes and Yaharn Su are named on this Form 483, for the inspection of Mar 30 – Apr 3, 2026. Each investigator has a profile showing what they cite most.
When was ChemPacific Corporation inspected by FDA?
The inspection ran Mar 30 – Apr 3, 2026, and the Form 483 is dated April 7, 2026.
How do I get the full Form 483 for ChemPacific Corporation?
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.