Medaus, Inc.
Form 483 issued March 11, 2016 · Birmingham, Alabama
- Inspection
- Mar 7 – Mar 11, 2016
- Investigators
- Claire M. Minden· Jennifer Del Valle
- Observations
- 9
- Pages
- 4
- FEI number
- 3001298034
In short: On March 11, 2016, FDA issued a Form 483 with 9 observations to Medaus, Inc. in Birmingham, Alabama (FEI 3001298034) after an inspection that ran Mar 7 – Mar 11, 2016. The investigators were Claire M. Minden and Jennifer Del Valle. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 6 of 9 observations.
Most cited: 21 CFR 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
There is no written testing program designed to assess the stability…
- 04
Buildings used in the manufacture, processing, packing, or holding of a drug product do not have…
This inspection in context
Claire M. Minden
26 documents · 2013–2022
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Louisiana.
The firmMedaus, Inc. history
All 5 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medaus, Inc.?
FDA listed 9 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Medaus, Inc.?
Claire M. Minden and Jennifer Del Valle are named on this Form 483, for the inspection of Mar 7 – Mar 11, 2016. Each investigator has a profile showing what they cite most.
When was Medaus, Inc. inspected by FDA?
The inspection ran Mar 7 – Mar 11, 2016, and the Form 483 is dated March 11, 2016.
How do I get the full Form 483 for Medaus, Inc.?
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.