Profounda Inc.
Form 483 issued August 9, 2022 · Orlando, Florida
- Inspection
- Aug 3 – Aug 9, 2022
- Investigator
- Harshal J. Desai
- Observations
- 6
- Pages
- 6
- FEI number
- 3011873350
In short: On August 9, 2022, FDA issued a Form 483 with 6 observations to Profounda Inc. in Orlando, Florida (FEI 3011873350) after an inspection that ran Aug 3 – Aug 9, 2022. The investigator was Harshal J. Desai. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 4 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01
Complaint records are deficient in that they do not include the findings of the…
- 02
Written records are not always made of investigations into unexplained discrepancies and the failure of a…
- 03
Laboratory controls do not include the establishment of scientifically sound and appropriate standards and test procedures…
- 04
Results of stability testing are not used in determining appropriate storage…
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 firmProfounda Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.198(b)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Profounda Inc.?
FDA listed 6 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Profounda Inc.?
Harshal J. Desai is named on this Form 483, for the inspection of Aug 3 – Aug 9, 2022. Each investigator has a profile showing what they cite most.
When was Profounda Inc. inspected by FDA?
The inspection ran Aug 3 – Aug 9, 2022, and the Form 483 is dated August 9, 2022.
How do I get the full Form 483 for Profounda 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.