MBi Distributing Inc. dba MBi
Amended 483 issued January 12, 2018 · Lindon, Utah
- Inspection
- Nov 15, 2017 – Jan 12, 2018
- Investigators
- Jeffrey P. Raimondi· Linda F. Murphy
- Observations
- 12
- Pages
- 32
- FEI number
- 3005482889
In short: On January 12, 2018, FDA issued a Amended 483 with 12 observations to MBi Distributing Inc. dba MBi in Lindon, Utah (FEI 3005482889) after an inspection that ran Nov 15, 2017 – Jan 12, 2018. The investigators were Jeffrey P. Raimondi and Linda F. Murphy. Most observations concern laboratory controls and materials; the most-cited regulation is 21 CFR 211.184 (component, drug product container, closure, and labeling records).
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
The responsibilities and procedures applicable to the quality control unit are not in…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
Written records of major equipment cleaning, maintenance and use are not included…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test…
8 more observations
Plus the full detail behind each one, exactly as FDA wrote it.
Get the full amended 483This inspection in context
Jeffrey P. Raimondi
40 documents · 2017–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmMBi Distributing Inc. dba MBi history
The site's inspection history, in date order.
Similar documentsOther sites cited under 211.22(d)
See how FDA wrote the same problem up elsewhere.
Questions about this amended 483
What did FDA find at MBi Distributing Inc. dba MBi?
FDA listed 12 observations on this Form 483, mostly about laboratory controls, materials and quality system. The most-cited regulation is 21 CFR 211.184 (component, drug product container, closure, and labeling records). The opening words of each observation are shown on this page.
Who inspected MBi Distributing Inc. dba MBi?
Jeffrey P. Raimondi and Linda F. Murphy are named on this Amended 483, for the inspection of Nov 15, 2017 – Jan 12, 2018. Each investigator has a profile showing what they cite most.
When was MBi Distributing Inc. dba MBi inspected by FDA?
The inspection ran Nov 15, 2017 – Jan 12, 2018, and the Amended 483 is dated January 12, 2018.
How do I get the full Amended 483 for MBi Distributing Inc. dba MBi?
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.