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TR: SO1210- product registration OP-00091031

Bonjour à tous,


Pour info relance du client. Merci de revenir vers eux



De : Largen Med Inc. <[email protected]>
Envoyé : mardi 31 août 2021 05:12
À : Olivier Meylan <[email protected]>
Objet : Re: SO1210- product registration


Hello Marianne,


How are you? So far, I'm doing good and am safe. I hope that you are doing well, too.


Haven't I sent you the samples of the files? As far as I can remember, I already sent them to you. However, if I haven't sent them to you, please see the attached file for your reference. Anyway, regarding your queries, here are my answers:

1. The certificate of analysis is the certification of the results upon testing the product. It should also include the testing methods the manufacturer has used. Also, this is presented per product.

2. You can submit either the sanitary, phytosanitary, or health certificate. But, if you can send me more than one among the list, it would be better - only if they are available. Certificates like the mentioned are for the manufacturing company and not for the products.

3. The product samples should be in their finished or commercial presentation, like, how it is supposed to look like when we'll put them on the market. You can send them to us later on; I will let you know if the FDA is already asking for them.  


Do you have a Viber? Please let me know so we can reach each other easier. Thanks, Marianne. 


On Fri, Aug 27, 2021 at 8:14 PM Marianne Abgrall <[email protected]> wrote:

Hello Angel,

I hope that you are safe and healthy.

We reviewed the list of required documents this week. My colleague is carrying on preparing the missing documents.

There is one requirement that we have noted at the beginning of our cooperation that is called “Our standard analysis”.

Since we will provide analysis for each products, I guess that those “standard analysis” are something global like explaining our usual set of controls?

Can you please tell us more? Would it be about listing our analysis criteria ? Or listing the regulations that are in accordance with our production?

Is this requirement still relevant? LARGEN did not mention it anymore.

Sanitary / Phyto- sanitary certificate

Does it apply to each product or does it only apply to the samples of finished product that we will provide for registration?

Health certificate

Does it apply to each product or does it only apply to the samples of finished product that we will provide for registration?

One sample in commercial presentation x 3

The samples may not be ready since the products will be registered before starting production.

Do FDA accept that we send for instance, the caps in a pill jar + a sample of a empty blister + a sample of a blank empty retail box ?

Do FDA need those samples to carry out analysis (microbiological…)?

Thank you in advance for your reply and I wish you a nice day. Nous vous remercions par avance pour votre réponse et vous souhaitons une agréable journée.
If you need any further information, do not hesitate to contact us. Nous restons à votre entière disposition pour tout renseignement complémentaire.

Yours faithfully. Cordialement.

Marianne ABGRALL • Executive Assistant

T +33 3 67 10 17 04 • W

Z.A rue de la Vieille Bruche, 67130 Muhlbach sur Bruche, France    

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par Olivier Meylan - 02:52 - 31 août 2021