5 replies to this topic

[Jchris]

Hello everyone, my facility just completed its annual International Milk Shipper audit.  We usually score above a 95 but this years audit had a strange deduction.During the plant walk through, the auditor noticed that an employee had a water bottle machine side.  The auditor said the FDA does not like screw cap water bottles and we would need to limit the container to a sport bottle style to eliminate the hand/mouth contact risk. We have had the same auditor for the last four years and he has never mentioned water bottles in the past. We are SQF certified as well and have never had an issue with how our policy if written during our SQF audits.  The policy is; water is allowed in clear plastic bottle with a closable lid. I have not been able to find any FDA rule or policy on this.  Can anyone point me to the specific FDA wording that does not allow this? Thanks.

[SQFconsultant]

It's a CS item. Get sippy tops.

[Jchris]

Thanks for the quick reply. Do you happen to know where in any FDA regulation this is covered?

[matthewcc]

Are you under Part 131 as a milk supplier?

 

I know this is probably not regulations that pertain to your operations, but for dietary supplements, Part 111, the following is required:

 

(8) Not eating food, chewing gum, drinking beverages, or using tobacco products in areas where components, dietary supplements, or any contact surfaces are exposed, or where contact surfaces are washed;...   §111.10(b)(8)

 

Therefore, if you have exposed product, product-contact equipment, or product-contact packaging, I don't think FDA would allow it.  Otherwise they might allow it.

 

Matthew

[Jchris]

We are a single service container manufacturer and only subject to appendix J.

[Slab]

Specifics like this isn't something the FDA would rule on, however in a broader scope;

 

Part 117,

subpart B 117.10

Personnel

Confining the following to areas other than where food may be exposed or where equipment or utensils are washed: eating food, chewing gum, drinking beverages, or using tobacco.

 

 

Part 117 is a fairly comprehensive GMP guidance for industry and this is all I could find. 

 

Having said that, from a mitigation angle those little screw caps are notorious for finding there way into unwanted places.