Michelex Corp (fka MLXO)

[sawdin]

Public Health Service
Food and Drug Administration


Central Region
Food and Drug Administration
Waterview Corporate Center
10 Waterview Blvd., 3rd Floor
Parsippany, NJ 07054

Telephone [phone]

April 16, 2007

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Venkat E. Kakani
President and COO
Medico Labs, Inc.
1000 Nottingham Way
Hamilton, New Jersey 08609

07-NWJ-10

Dear Mr. Kakani:

An inspection of your manufacturing facility located at 1000 Nottingham Way, Hamilton, NJ was conducted from November 2 through November 16, 2006. During the inspection, our investigator documented deviations from the Current Good Manufacturing Practice (CGMP) Regulations, Title 21 Code of Federal Regulations, Parts 210 and 211 (21 CFR 210 and 211) for drug products manufactured and tested at this site. These deviations cause your drug products to be adulterated within the meaning of Section 501(a)(2)(B) of the Food, Drug and Cosmetic Act (the Act) (21 U.S.C. section 351(a)(2)(B)), and are as follows:
Full Letter