4 replies to this topic

[oacosta60]

Ideas of how to handle the following FDA observation: Your plant was not constructed to facilitate maintenance and sanitary operations.

[Tony-C]

Hi oacosta60,

 

I would request that they are more specific, the observation is too broad brush.

 

Kind regards,

 

Tony

[G M]

Agreed that it is overly vague. 

 

I would have to guess it alludes to the materials the production area is constructed of (impervious materials suitable for wet washing, with numerous floor drains).  Perhaps you can tell us what the building is made of, or if it was retrofitted from some other type of use -- and generally speaking what you produce.

[Brothbro]

Can you give us details on what exactly the FDA observed? FDA observations typically start with a general statement that echoes the regulatory code, but are followed by "Specifically, ...." After this "specifically" the report will list precisely what was observed. The best course of action is to correct precisely what caused the observation. 

 

An example:

 

"Your plant was not constructed to facilitate maintenance and sanitary operations. Specifically, the metal roof above the product receiving area showed signs of rust and flaking paint."

 

Obviously the corrective action would be to repair this section of the roof.

[oacosta60]

That was only the information I received. I will check with the person that have the concern.

 

Oscar