Pharmaceutics International Inc
Form 483 issued December 6, 2024 · Hunt Valley, Maryland
- Inspection
- Dec 2 – Dec 6, 2024
- Investigator
- Young K. Chou
- Observations
- 4
- Pages
- 5
- FEI number
- 1000513101
In short: On December 6, 2024, FDA issued a Form 483 with 4 observations to Pharmaceutics International Inc in Hunt Valley, Maryland (FEI 1000513101) after an inspection that ran Dec 2 – Dec 6, 2024. The investigator was Young K. Chou. Most observations concern facilities & equipment and materials.
At a glance
Facilities & equipment and materials account for 3 of 4 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
Reports of analysis from component suppliers are accepted in lieu of testing each component for conformity…
- 03
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are…
- 04
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
This inspection in context
Young K. Chou
1 document · 2024
Cites 211.160(b)(4) (general requirements) more than any other section. Most of their documents are for sites in Maryland.
The firmPharmaceutics International Inc history
All 11 documents on file for this site, in date order, with what was cited at each inspection.
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 Pharmaceutics International Inc?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, materials and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Pharmaceutics International Inc?
Young K. Chou is named on this Form 483, for the inspection of Dec 2 – Dec 6, 2024. Each investigator has a profile showing what they cite most.
When was Pharmaceutics International Inc inspected by FDA?
The inspection ran Dec 2 – Dec 6, 2024, and the Form 483 is dated December 6, 2024.
How do I get the full Form 483 for Pharmaceutics International 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.