Document EzjaR96NjJoJqoMnG9odpMYN
March 18, 1993
To: Mark Hross
SUBJECT: GEON RAW MATERIAL FDA STATUS
This is in response to your request for assistance in determining what FDA indirect food additive clearances exist for selected Geon raw materials. The purpose of this letter is to explain the process, to provide issues that need to be considered, and to provide recommendations relevant to this specific task and future needs.
Before we get into the meat of this subject, it is important to note that FDA goes to lengths to emphasize that they do not "approve" any product. The proper terms to use are "clearance", or, "acceptability".
Determination of the acceptability and raw materials for indirect food additive applications is the prime responsibility of the manufacturer. Only the manufacturer has the information necessary to determine whether its product (chemistry, purity, and process) meets the requirements of the various indirect food additive sections.
Once the supplier provides a list of the specific clearances for their raw material (i.e., 21CFR175.105, 21CFR177.2600, etc.), we verify the chemical's listing and note specific limitations prior to determining what clearances the Geon compound has. Frequently,--issues arise which require further information from----the supplier, or resolution via external opinions.
In the past, Chuck Purks was the person responsible for contacting suppliers and obtaining information on the FDA clearances for their products. While this is something that we could do, it is probably not the best way to manage the process particularly in light of Geon's decision to assume full responsibility for its FDA activities in 1994. Furthermore, we cannot assume this task and still handle the daily FDA, USDA, and NSF activities, as well as the FDA audit.
In order for Geon to be prepared to insure compliance and provide timely responses to customer needs, it is essential that Geon obtain the staff necessary to meet these needs.
Bob Hinderer
0318-1/jp
cc: L. Maresca D. Marshall M. Marshall
c. Mattia K. Willings
21762001
BFG16456
To: R. Hinderer - OTM-3 cc: D. Marshall - OTM-2
INTEROFFICE MEMORANDUM
Date: From: Dept: Phone: Loc:
March 18, 1993 M. Hross Unknown x7601 OTM-3
RECEIVED ,,. MAR 1 8 1993
RR.. HINDERER
Subject: FDA Approvals and Restrictions for Select Geon Raw Materials
Under our contract agreement for FDA support, please find attached a list of sixteen Geon raw materials which have conflicting FDA approval statements from our suppliers. That is, these raw materials have multiple suppliers with conflicting FDA information supplied by each.
At your earliest convenience please supply FDA approvals and restrictions (listing appropriate
references) for use of each of the attached raw materials. Please note that the raw material
chemistries are also attached.
<
Your supplied information will then be used to resolve the conflicts in our database.
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