USpharma Ltd
Form 483 issued June 23, 2022 · Miami Lake, Florida
- Inspection
- Jun 13 – Jun 23, 2022
- Investigator
- Jennifer Lalama
- Observations
- 3
- Pages
- 4
- FEI number
- 1010370
In short: On June 23, 2022, FDA issued a Form 483 with 3 observations to USpharma Ltd in Miami Lake, Florida (FEI 1010370) after an inspection that ran Jun 13 – Jun 23, 2022. The investigator was Jennifer Lalama. Most observations concern laboratory controls and quality system.
At a glance
2 of 3 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
The sensitivity of test methods…
- 02
Laboratory records are deficient in that they do not include a complete record of all…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Jennifer Lalama
31 documents · 2015–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Florida.
The firmUSpharma Ltd history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.165(e)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at USpharma Ltd?
FDA listed 3 observations on this Form 483, mostly about laboratory controls and quality system. The opening words of each observation are shown on this page.
Who inspected USpharma Ltd?
Jennifer Lalama is named on this Form 483, for the inspection of Jun 13 – Jun 23, 2022. Each investigator has a profile showing what they cite most.
When was USpharma Ltd inspected by FDA?
The inspection ran Jun 13 – Jun 23, 2022, and the Form 483 is dated June 23, 2022.
How do I get the full Form 483 for USpharma Ltd?
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.