Wayzata Bay Products Inc 19-Dec-01

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration

Minneapolis District

240 Hennepin Avenue

Minneapolis, MN 55401-1999

Telephone. 612-334-4100

December 19, 2001

WARNING LETTER

CERTIFIED MAIL

RETURN RECEIPT REQUESTED Refer to MIN 02 - 17

Jon C. Ratliff

President and Owner

Wayzata Bay Products, Inc.

4358 South County Road 92

St. Bonifacius, Minnesota 55375

Dear Mr. Ratliff:

During our inspection of your Wayzata Bay Products, Inc., an over-the-counter

(OTC) drug manufacturing operation located in St. Bonifacius, MN, on October 15,

16, 23, and 3 1, 200 1, our investigator found serious violations of the Current Good

Manufacturing Practices (GMPs) for Finished Pharmaceuticals, Title 21, Code of

Federal Regulations, Part 211 (21 CFR 211). Your OTC drug product is adulterated

within the meaning of Section 50l(a)(2)(B) of the Federal Food, Drug and Cosmetic

Act (the Act).

The violations observed during our inspection include, but are not limited to, the

following:

1. Failure to assure that each person engaged in the manufacturing, processing, packing, or holding of a drug product shall have the education, training, experience to enable that person to perform the assigned functions [21 CFR 211.25( a )] in that there is no documentation of current cGMP training for your employee.

2. Failure to have a written testing program designed to assess the stability characteristics of drug products (21 CFR 211.166).

3. Failure to have an expiration date on your OTC product or, in lieu of expiration dating, failure to have appropriate stability data for at least three years to support the lack of an expiration date on your OTC drug product [21 CFR 211.137(a) and (h)].

4. Failure to have appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including identification and strength for each active ingredient [21 CFR 211.165(a)] in that there is no finished product testing for your OTC drug product.

5. Failure to have written procedures for production and process control designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. Such procedures shall be followed in the execution of the various production and process control functions [21 CFR 211.100 (a) and (b)] in that no formal protocol has been prepared for the validation of the water system, nor has

your water system been validated.

The above indication of violations is not intended to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure adherence with each

requirement of the Good Manufacturing Practice Regulations. Federal agencies are

advised of the issuance of all Warning Letters about drugs so they may take this

information into account when considering the award of contracts.

You should take prompt action to correct these deviations. Failure to promptly correct these deviations may result in regulatory action without further notice. Possible actions include seizure and/or injunction. This is official notification that FDA expects all your locations to be in compliance.

You should notify this office in writing, within 15 working days of receipt of this

letter, of specific steps you have taken to correct the noted violations, including an

explanation of each step being taken to prevent the recurrence of similar violations.

If corrective action cannot be completed within 15 working days, state the reason

for the delay and the time within which the corrections will be completed.

In addition, removing "sanitizing" from the labeling does not alter the categorization

of your waterless hand sanitizing gel as a drug. Its labeling does not make it a drug; the ingredients make this product a drug.

Your reply should be sent to Compliance Officer Carrie A. Hoffman at the address

on the letterhead.

Sincerely,

David R. Yost

Acting Director

Minneapolis District