Micro-Macinazione SA
Form 483 issued May 31, 2019 · MONTEGGIO, Switzerland
- Inspection
- May 31, 2019
- Investigator
- Edmund F. Mak
- Observations
- 2
- Pages
- 2
- FEI number
- 3002807618
In short: On May 31, 2019, FDA issued a Form 483 with 2 observations to Micro-Macinazione SA in MONTEGGIO, TI (FEI 3002807618) after an inspection that ran May 31, 2019. The investigator was Edmund F. Mak. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your investigations of drug substance quality complaints do not always adequately determine the full scope of…
- 02
You do not maintain non-dedicated production equipment in a good state of repair necessary to minimize…
This inspection in context
Edmund F. Mak
1 document · 2019
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Switzerland.
The firmMicro-Macinazione SA history
The site's inspection history, in date order.
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 Micro-Macinazione SA?
FDA listed 2 observations on this Form 483, mostly about quality system and facilities & equipment. 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 Micro-Macinazione SA?
Edmund F. Mak is named on this Form 483, for the inspection of May 31, 2019. Each investigator has a profile showing what they cite most.
When was Micro-Macinazione SA inspected by FDA?
The inspection ran May 31, 2019, and the Form 483 is dated May 31, 2019.
How do I get the full Form 483 for Micro-Macinazione SA?
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.