| Public Health Service Food and Drug Administration |
| Detroit District 300 River Place Suite 5900 Detroit, MI 48207 Telephone: 313-393-8100 FAX: 313-393-8139 |
Department of Health and Human ServicesWARNING LETTER
2011 DET-03
October 18, 2010
VIA UPS
Mr. Stephen W. Golsby, President, CEO, and Director
Mead Johnson Nutrition Company
2701 Patriot Boulevard
Glenview, Illinois 60026-8039
Dear Mr. Golsby:
The Food and Drug Administration (FDA) conducted an investigation of your infant formula processing facility, Mead Johnson Nutrition, located at 2400 West Lloyd Expressway, Evansville, Indiana on September 9, 13-17, 20, and 22-23, 2010. Your firm blends and packages powdered infant formula at this location, Based on our investigation, we have concluded that your Enfamil Premium Infant, Enfamil Gentlease, and Enfamil AR, powdered infant formula are in violation of the Federal Food, Drug and Cosmetic Act (the Act) and the applicable regulations at Title 21, Code of Federal Regulations, Part 106 and 107 (21 CFR 106 and 107), You can find copies of the Act and these regulations through links in FDA's home page at www.fda.gov
Our investigation determined that your firm failed to provide the specifications for the plastic tub and lid assembly in which pouches of Enfamil Premium Infant, Enfamil Gentlease, and Enfamil A,R, infant formula pouches are packaged and marketed, Failure to notify the FDA at least ninety (90) days prior to marketing a new infant formula or formula with a major change is in violation of the Federal Food, Drug, and Cosmetic Act (the Act) Section 412(c)(2)(B), [21 U,S,C, § 350a(c)(2)(B)], Failure to comply with Section 412(c)(2)(B), [21 U,S,C, § 350a(c)(2)(B)] of the Act is a prohibited act under Section 301(s) of the Act [21 U,S,C, § 331(s)],
Specifically, your firm advised the FDA in a notification dated February 26, 2010 that it would begin to blend and package infant formula powder in multi-serve pouches at you facility located in Evansville, Indiana, However, the notification did not include the specifications for the polypropylene tub and lid which is used for packaging the infant formula pouches, Labeling on the product suggests that the powder may be transferred from the pouch to the plastic tub for storage purposes, If used in this manner, the tub and lid become a food contact surface, As required by Title 21, Code of Federal Regulations (21 CFR), Section 106.30(c)(2), the manufacturer of infant formula shall evaluate the effect of changes in processing conditions that could affect the level of nutrients in the finished product. Your notification does not identify the tub and lid as a food contact surface, and does not include an evaluation of the plastic used for the tub and lid.
You should notify this office, in writing, describing the corrective actions that you will take to bring your firm into compliance within fifteen (15) working days of receiving this letter. Your response should include each corrective action that you have or will take to correct these violations and prevent their recurrence. Please include copies of any documentation that demonstrates that the corrections have been made.
Your written response should be sent to Tina M. Pawlowski, Ph.D., Compliance Officer, U.S. Food and Drug Administration, 300 River Place, Suite 5900, Detroit, MI 48207. If corrective actions cannot be completed within fifteen (15) working days of receiving this letter, please state the reason for the delay and the time frame in which they will be completed. If you have any questions concerning this letter, please contact Compliance Officer Pawlowski at (313) 393-8217 or by e-mail at tina.pawlowski@fda.hhs.gov.
Sincerely,
/S/
Joann M. Givens
Detroit District Director
Detroit District Office
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