Medaus, Inc.
Form 483 issued March 22, 2013 · Birmingham, Alabama
- Inspection
- Mar 18 – Mar 22, 2013
- Investigators
- Bruce H. McCullough· Meisha R. Waters
- Observations
- 12
- Pages
- 6
- FEI number
- 3001298034
In short: On March 22, 2013, FDA issued a Form 483 with 12 observations to Medaus, Inc. in Birmingham, Alabama (FEI 3001298034) after an inspection that ran Mar 18 – Mar 22, 2013. The investigators were Bruce H. McCullough and Meisha R. Waters. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and laboratory controls account for 8 of 12 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 02
Protective apparel is not worn as necessary to protect…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Bruce H. McCullough
2 documents · 2013
Cites 211.42(c)(10)(iii) (design and construction features) more than any other section. Most of their documents are for sites in Alabama.
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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medaus, Inc.?
FDA listed 12 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. 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.?
Bruce H. McCullough and Meisha R. Waters are named on this Form 483, for the inspection of Mar 18 – Mar 22, 2013. Each investigator has a profile showing what they cite most.
When was Medaus, Inc. inspected by FDA?
The inspection ran Mar 18 – Mar 22, 2013, and the Form 483 is dated March 22, 2013.
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.