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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Test WL 6-14

 

WARNING LETTER

Via UPS
Delivery Signature Requested
 
May 31, 2011

Chungchiang Hsu, President and CEO
Impax Laboratories, Inc.
31153 San Antonio Street
Hayward, CA 94544

Ref: FEI 3004182921

Dear Mr. Hsu:

During our December 13, 2010 through January 21, 2011 inspection of your pharmaceutical manufacturing facility, Impax Laboratories, Inc., located at 31153 San Antonio Street, Hayward, CA, investigators 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 CGMP violations cause your 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. § 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 reviewed your firm’s response dated February 11, 2011, and note it lacks sufficient corrective actions.

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

1. Your firm has not established written procedures to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and drug product [21 C.F.R. § 211.110(a)]. For example: