3 replies to this topic

[mtelander]

We are a dietary supplement contract manufacturer and our leadership needs ironclad verbiage as to why they CAN't ship under qurantine. Does anyone have any iron clad guidance on how we can explain why we cant ship under quarantine?

[jfrey123]

Probably depends on the reason for quarantine, but if it's because the product is believed to be adulterated in any way then that's your reason right there.  FDA has some pretty strong language about putting adulterated product out into the market.

 

Now that's different from companies who specify their 'finished' good is intended for further processing.  Those companies are admitting their product is not ready for consumption but acknowledging that the customer they're supplying is aware and has a process control in place to handle the risk.  But I take it that's not what you mean here?

[mtelander]

Well for us, shipping under quarantine usually means a customer wants their product BEFORE testing has come back proving that the finished product meets spec for purity, strength, etc. We have typically held a position of NOT shipping under quarantine but our leadership thinks that since their isnt iron clad language that we can so i was wondering if anyone had any experience or direction towards a reg i could use

[Scampi]

what is leaderships plan for product when it fails to meet your parameters?

 

maybe this

Shipping dietary supplements prior to receiving final lab testing results is a major violation of FDA Current Good Manufacturing Practices (cGMPs). Under 21 CFR Part 111, manufacturers must test finished products to ensure they meet specifications for identity, purity, strength, and composition before they are released for distribution

 

Quality means that the dietary supplement consistently meets the established specifications for identity, purity, strength, and composition, and limits on contaminants, and has been manufactured, packaged, labeled, and held under conditions to prevent adulteration under section 402(a)(1), (a)(2), (a)(3), and (a)(4) of the act.

 

You must provide adequate documentation of your basis for determining that compliance with the specification(s) selected under paragraph ©(1) of this section, through the use of appropriate tests or examinations conducted under paragraph ©(2) of this section, will ensure that your finished batch of the dietary supplement meets all product specifications for identity, purity, strength, and composition, and the limits on those types of contamination that may adulterate, or that may lead to the adulteration of, the dietary supplement; and

(4) Your quality control personnel must review and approve the documentation that you provide under paragraph ©(3) of this section.

 

https://www.ecfr.gov...pter-B/part-111