Icrom SRL
Form 483 issued March 22, 2019 · Concorezzo, Italy
- Inspection
- Mar 18 – Mar 22, 2019
- Investigators
- Marcus A. Ray· Philip F. Istafanos
- Observations
- 10
- Pages
- 12
- FEI number
- 3007410503
In short: On March 22, 2019, FDA issued a Form 483 with 10 observations to Icrom SRL in Concorezzo, (MB) (FEI 3007410503) after an inspection that ran Mar 18 – Mar 22, 2019. The investigators were Marcus A. Ray and Philip F. Istafanos. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Facilities & equipment and quality system account for 6 of 10 observations.
Most cited: 21 CFR 211.160 (3×) · 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Specifically, ‘You failed to prevent the potential cross contamination of API product by not adequately cleaning…
- 02
The quality unit does not have the responsibility for approving or rejecting all…
- 03
Established test procedures are not documented at the…
- 04
Appropriate written procedures designed to prevent objectionable microorganisms in drug products not required to be sterile…
This inspection in context
Marcus A. Ray
14 documents · 2017–2025
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in China.
The firmIcrom SRL history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Icrom SRL?
FDA listed 10 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Icrom SRL?
Marcus A. Ray and Philip F. Istafanos are named on this Form 483, for the inspection of Mar 18 – Mar 22, 2019. Each investigator has a profile showing what they cite most.
When was Icrom SRL inspected by FDA?
The inspection ran Mar 18 – Mar 22, 2019, and the Form 483 is dated March 22, 2019.
How do I get the full Form 483 for Icrom 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.