Dextrum Laboratories Inc
Form 483 issued August 29, 2024 · Miami, Florida
- Inspection
- Aug 19 – Aug 29, 2024
- Investigators
- J'maica J. Hunter· Jennifer Lalama
- Observations
- 6
- Pages
- 4
- FEI number
- 3003092372
In short: On August 29, 2024, FDA issued a Form 483 with 6 observations to Dextrum Laboratories Inc in Miami, Florida (FEI 3003092372) after an inspection that ran Aug 19 – Aug 29, 2024. The investigators were J'maica J. Hunter and Jennifer Lalama. Most observations concern production and facilities & equipment.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 02
Component testing is deficient in that each component is not tested for conformity with all appropriate…
- 03
The written stability testing…
- 04
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
J'maica J. Hunter
5 documents · 2024–2026
Cites 211.110 (sampling and testing of in-process materials and drug products) more than any other section. Most of their documents are for sites in Georgia.
The firmDextrum Laboratories Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.63
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dextrum Laboratories Inc?
FDA listed 6 observations on this Form 483, mostly about production, facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected Dextrum Laboratories Inc?
J'maica J. Hunter and Jennifer Lalama are named on this Form 483, for the inspection of Aug 19 – Aug 29, 2024. Each investigator has a profile showing what they cite most.
When was Dextrum Laboratories Inc inspected by FDA?
The inspection ran Aug 19 – Aug 29, 2024, and the Form 483 is dated August 29, 2024.
How do I get the full Form 483 for Dextrum Laboratories 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.