Pharmaceuticals

October 12, 2010

WARNING LETTER

CIN-11-108087-01

Via United Parcel Service

Gregory A. Neal
President and Owner
Advanced Testing Laboratory, Inc.
6954 Cornell Road, Suite 200
Cincinnati, Ohio 45242

Dear Mr. Neal:


During our February 18, 2010 to April 9, 2010 inspection of your pharmaceutical contract testing laboratory, Advanced Testing Laboratory, Inc., located at 6954 Cornell Road, Cincinnati, Ohio, an investigator from the Food and Drug Administration (FDA) identified significant violations of Current Good Manufacturing Practice (CGMP) regulations for Finished Pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause your client's drug product(s) to be adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. ยง 351(a)(2)(B)] in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP.

We have reviewed your firm's response of April 29, 2010, and note that it lacks sufficient corrective actions.

Specific violations observed during the inspection include, but are not limited, to the following: