Mipharm SPA
Form 483 issued September 22, 2023 · MILANO, Italy
- Inspection
- Sep 18 – Sep 22, 2023
- Investigator
- Rajiv R. Srivastava
- Observations
- 3
- Pages
- 5
- FEI number
- 3002807647
In short: On September 22, 2023, FDA issued a Form 483 with 3 observations to Mipharm SPA in MILANO, Italy (FEI 3002807647) after an inspection that ran Sep 18 – Sep 22, 2023. The investigator was Rajiv R. Srivastava. 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 observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Testing and release of drug products for distribution do not include appropriate laboratory determination of satisfactory…
- 02
The written stability program for drug products does not…
- 03
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
This inspection in context
Rajiv R. Srivastava
30 documents · 2018–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmMipharm SPA history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.165
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Mipharm SPA?
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 Mipharm SPA?
Rajiv R. Srivastava is named on this Form 483, for the inspection of Sep 18 – Sep 22, 2023. Each investigator has a profile showing what they cite most.
When was Mipharm SPA inspected by FDA?
The inspection ran Sep 18 – Sep 22, 2023, and the Form 483 is dated September 22, 2023.
How do I get the full Form 483 for Mipharm SPA?
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.