Medaus, Inc.
FDA document issued May 3, 2016 · Birmingham, Alabama
- Inspection
- Mar 7 – Mar 11, 2016
- Observations
- 4
- Pages
- 3
In short: On May 3, 2016, FDA issued a FDA document with 4 observations to Medaus, Inc. in Birmingham, Alabama after an inspection that ran Mar 7 – Mar 11, 2016. Most observations concern production and materials; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and materials account for 3 of 4 observations.
Most cited: 21 CFR 211.113 (2×)
What the letter cites
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The movement of supplies and materials into the critical ISO 5 zone…
- 02
Red tape used on the working surface of the ISO 5 laminar flow…
- 03
Bottles of(b) (4 ) with screw-top lids that were stored in the refrigerators located in the…
- 04
You have failed to provide and maintain a controlled environment suitable for the processing…
This record's details are shown as context for the site. The file isn't for sale.
This inspection in context
Questions about this document
When was Medaus, Inc. inspected by FDA?
The inspection ran Mar 7 – Mar 11, 2016, and the FDA document is dated May 3, 2016.