Cambrex Profarmaco Milano SRL
Form 483 issued May 19, 2017 · MILANO, Italy
- Inspection
- May 15 – May 19, 2017
- Investigators
- Margaret M. Annes· Temar Q. Williams
- Observations
- 8
- Pages
- 5
- FEI number
- 3003723076
In short: On May 19, 2017, FDA issued a Form 483 with 8 observations to Cambrex Profarmaco Milano SRL in MILANO, Italy (FEI 3003723076) after an inspection that ran May 15 – May 19, 2017. The investigators were Margaret M. Annes and Temar Q. Williams. Most observations concern laboratory controls and facilities & equipment.
At a glance
Laboratory controls and facilities & equipment account for 6 of 8 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
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
Buildings used in the manufacturing, processing, packing, and holding of a drug product are not maintained…
This inspection in context
Margaret M. Annes
60 documents · 2007–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Texas.
The firmCambrex Profarmaco Milano SRL history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cambrex Profarmaco Milano SRL?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The opening words of each observation are shown on this page.
Who inspected Cambrex Profarmaco Milano SRL?
Margaret M. Annes and Temar Q. Williams are named on this Form 483, for the inspection of May 15 – May 19, 2017. Each investigator has a profile showing what they cite most.
When was Cambrex Profarmaco Milano SRL inspected by FDA?
The inspection ran May 15 – May 19, 2017, and the Form 483 is dated May 19, 2017.
How do I get the full Form 483 for Cambrex Profarmaco Milano SRL?
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.