Latina Pharma S.P.A
Form 483 issued April 21, 2017 · Sermoneta, Italy
- Inspection
- Apr 10 – Apr 21, 2017
- Investigators
- Amir Alavi· Linda F. Murphy
- Observations
- 6
- Pages
- 7
- FEI number
- 3001229385
In short: On April 21, 2017, FDA issued a Form 483 with 6 observations to Latina Pharma S.P.A in Sermoneta, Latina (FEI 3001229385) after an inspection that ran Apr 10 – Apr 21, 2017. The investigators were Amir Alavi and Linda F. Murphy. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Laboratory controls and production account for 5 of 6 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review any unexplained discrepancy or the failure of a batch…
- 02
Procedures designed to prevent microbiological contamination of drug substances purporting to be…
- 03
Reprocessing has not been validated to demonstrate reprocessing does not alter properties of the product, such…
- 04
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to…
This inspection in context
Amir Alavi
9 documents · 2017–2024
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in California.
The firmLatina Pharma S.P.A history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Latina Pharma S.P.A?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, production and quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Latina Pharma S.P.A?
Amir Alavi and Linda F. Murphy are named on this Form 483, for the inspection of Apr 10 – Apr 21, 2017. Each investigator has a profile showing what they cite most.
When was Latina Pharma S.P.A inspected by FDA?
The inspection ran Apr 10 – Apr 21, 2017, and the Form 483 is dated April 21, 2017.
How do I get the full Form 483 for Latina Pharma S.P.A?
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.