| |
RETAIL
BUYERS GUIDE
|
|
| |
Page 1 of 2
|
|
| |
This
guide is to help you compare different manufacturers.
It provides you with specific questions so you can effectively
compare "apples to apples." The Retail Buyer's
Guide allows you to be informed and make decisions based
on facts, rather than using guesswork to find out how
others are manufacturing their supplements. Here are some
facts about Vitamer Labs®. |
|
| |
|
|
| |
| Company: |
Vitamer
Labs®, a Division of Nexgen Pharma
Inc. |
| Contact
Name: |
Jane
Drinkwalter, Vice President, Sales |
| Address: |
46 Corporate Park, Irvine, CA 92606-3121 |
| Product
Line: |
Private
label dietary supplements |
| Owners: |
Shareholders
– majority owner is Steven R. Brown,
President |
|
|
|
| |
|
|
| |
Code
of ethics: |
|
| |
We
adhere to the codes of ethics of the professional
organizations Natural Products Association.
|
|
| |
|
|
| |
Trade
group membership: |
|
| |
- Natural Products Association (NPA)
- Organic Trade Association
|
|
| |
|
|
| |
Permits and Registrations: |
|
| |
- FDA
Registration for Pharmaceutical Manufacturing
- Registered
with the Drug Enforcement Administration
- Licensed
through the California Department of Health Services
for the following:
- Drug
manufacturing
- Processed
food registration (required for food supplement
manufacturers)
- California
State Board of Pharmacy
- Certified Organic by QAI
|
|
| |
|
|
| |
Licensed
to produce over-the-counter (OTC) drug products? |
|
| |
YES.
|
|
| |
|
|
| |
Is
facility available for visits by customers or trade group
representatives? |
|
| |
YES.
|
|
| |
|
|
| |
Do
we operate our own manufacturing facilities? Are any products
manufactured for us by other companies? |
|
| |
We
manufacture tablets and capsules in our own facilities.
We purchase liquids, protein powders and soft gelatin
capsules from outside vendors.
|
|
| |
|
|
| |
What
control mechanisms are in place to ensure quality control
in the manufacturing process? |
|
| |
Adherence
to 21CFR210, 211 (Code of Federal Regulations)
|
|
| |
|
|
| |
How
are personnel qualified? |
|
| |
We
have a comprehensive staff of degreed professionals
and are happy to provide that information up request.
Call or write for details.
|
|
| |
|
|
| |
Are
raw materials tested when received? By what methods? |
|
| |
Raw
materials are tested when received Methods used: USP,
NF, AOAC, or FCC. In some instances assay methods
are developed and validated by our chemists.
|
|
| |
|
|
| |
What
type of record keeping do we maintain to ensure an adequate
audit trail for products and their ingredients? |
|
| |
We
maintain records as required by the Code of Federal
Regulations.
|
|
| |
|
|
| |
Do
we batch test? How frequently? |
|
| |
We
batch test every lot before it is released for packaging.
|
|
| |
|
|
| |
How
long are samples retained? |
|
| |
Samples
are retained at least one (1) year after the
best by date.
|
|
| |
|
|
| |
Are
there written specifications for the raw materials? |
|
| |
YES.
|
|
| |
|
|
