Dextrum Laboratories Inc
Form 483 issued December 16, 2022 · Miami, Florida
- Inspection
- Dec 12 – Dec 16, 2022
- Investigator
- Harshal J. Desai
- Observations
- 10
- Pages
- 6
- FEI number
- 3003092372
In short: On December 16, 2022, FDA issued a Form 483 with 10 observations to Dextrum Laboratories Inc in Miami, Florida (FEI 3003092372) after an inspection that ran Dec 12 – Dec 16, 2022. The investigator was Harshal J. Desai. Most observations concern production and facilities & equipment.
At a glance
Production and facilities & equipment account for 6 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures prescribing a system for reprocessing batches to insure that the reprocessed batches will conform with…
- 02
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate…
- 03
There was a failure to handle and store components at all times in a…
- 04
Procedmes designed to prevent objectionable microorganisms in drug products not required to be sterile are…
This inspection in context
Harshal J. Desai
6 documents · 2022–2024
Cites 211.100(a) (written procedures; deviations) more than any other section. Most of their documents are for sites in Florida.
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 211.115(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Dextrum Laboratories Inc?
FDA listed 10 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Dextrum Laboratories Inc?
Harshal J. Desai is named on this Form 483, for the inspection of Dec 12 – Dec 16, 2022. Each investigator has a profile showing what they cite most.
When was Dextrum Laboratories Inc inspected by FDA?
The inspection ran Dec 12 – Dec 16, 2022, and the Form 483 is dated December 16, 2022.
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.