R. Mason (Chemicals) Ltd
Form 483 issued July 21, 2016 · Stanley, United Kingdom
- Inspection
- Jul 18 – Jul 21, 2016
- Observations
- 4
- Pages
- 2
- FEI number
- 3002808015
In short: On July 21, 2016, FDA issued a Form 483 with 4 observations to R. Mason (Chemicals) Ltd in Stanley, County Durham (FEI 3002808015) after an inspection that ran Jul 18 – Jul 21, 2016.
What FDA observed
Preview: the opening words of each observation- 01
You do not have an ongoing stability program for your (6) (4) USP API product to…
- 02
You have not conducted cleaning validation to support the cleaning activities performed throughout the manufacturing operations…
This inspection in context
Questions about this 483
What did FDA find at R. Mason (Chemicals) Ltd?
FDA listed 4 observations on this Form 483. The opening words of each observation are shown on this page.
When was R. Mason (Chemicals) Ltd inspected by FDA?
The inspection ran Jul 18 – Jul 21, 2016, and the Form 483 is dated July 21, 2016.
How do I get the full Form 483 for R. Mason (Chemicals) Ltd?
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.