ChemPacific Corporation
Form 483 issued February 15, 2024 · Baltimore, Maryland
- Inspection
- Feb 6 – Feb 15, 2024
- Investigators
- Azeezat M. Lawal· David A. Oluwo
- Observations
- 6
- Pages
- 7
- FEI number
- 3003299802
In short: On February 15, 2024, FDA issued a Form 483 with 6 observations to ChemPacific Corporation in Baltimore, Maryland (FEI 3003299802) after an inspection that ran Feb 6 – Feb 15, 2024. The investigators were Azeezat M. Lawal and David A. Oluwo. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
The investigations into unexplained discrepancies are not thorough and conclusions have not been established…
- 03
Buildings used in the manufacturing and holding of active pharmaceutical ingredients are not maintained in a…
- 04
The batch production and control records for active pharmaceutical ingredients do not include complete information relating…
This inspection in context
Azeezat M. Lawal
8 documents · 2023–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Maryland.
The firmChemPacific Corporation history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ChemPacific Corporation?
FDA listed 6 observations on this Form 483, mostly about facilities & equipment, quality system and production. The opening words of each observation are shown on this page.
Who inspected ChemPacific Corporation?
Azeezat M. Lawal and David A. Oluwo are named on this Form 483, for the inspection of Feb 6 – Feb 15, 2024. Each investigator has a profile showing what they cite most.
When was ChemPacific Corporation inspected by FDA?
The inspection ran Feb 6 – Feb 15, 2024, and the Form 483 is dated February 15, 2024.
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.