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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Mackie International, Inc. 31-Aug-05

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Los Angeles District

19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900


WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

W/L 19-05

August 31, 2005

Ms. Carmel Canete, Controller
Mackie International, Inc.
1900 South Tubeway Avenue
Los Angeles, CA 90040-1612

Dear Ms. Canete:

From December 7-13, 2004, an investigator from the U.S. Food and Drug Administration conducted an inspection of your firm to determine your compliance with the Federal Food, Drug and Cosmetic Act (the Act) and the regulations in Title 2l, Code of Federal Regulations Our analysis of a sample of your product [redacted] shows serious violations of the Act. You can find the Act and regulations through links on FDA's Internet home page at www.fda.gov.

During the inspection, the investigator collected a sample of your [redacted] 8 oz. bottles, best by date July 22, 2006, and labeled for distribution by [redacted]. Based on our analysis of the sample, which was completed on April 21, 2005, we conclude that the product is misbranded under section 403(a)(1) of the Act [21 USC 343(a)(l)], in that the label is false and misleading because the amounts of sodium, potassium, and chloride found in the product are greater than the amounts declared on the product label. The findings are as follows:

Nutrient

Label declaration

Original analysis

Check analysis

Sodium

45 mEq

65.6 mEq (146%)

65.3 mEq (145%)

Potassium

20 mEq

30.6 mEq (153%)

28.8 mEq (144%)

Chloride

35 mEq

42.8 mEq (122%)

47 mEq (134%)

The above violations are not meant to be an all-inclusive list of deficiencies at your facility. It is your responsibility to ensure that products marketed by your firm comply with all the requirements of the Act and its implementing regulations.

You should take prompt action to-correct these violations. Failure to promptly correct these deviations may result in regulatory action being initiated by the Food and Drug Administration without further notice. These actions include, but are not limited to, seizure and injunction.

Please notify this office within 15 working days of receipt of this letter of the specific steps you have taken to correct the noted violations, including an explanation of each step being taken to assure that similar violations will not recur. 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 implemented.

Your response should be sent to:
Pamela B. Schweikert, Director of Compliance
U.S. Food and Drug Administration
19701 Fairchild
Irvine, CA 92612

Sincerely,

/S/

Alonza Cruse
District Director
Los Angeles District