On August 27, 2012, the FDA issued a warning letter to DPT Lakewood, LLC, located in New Jersey. The beginning of the letter states:
During our February 15 to March 7, 2012 inspection of your pharmaceutical
manufacturing facility located at 1200 Paco Way, Lakewood , NJ, 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 drug product, Santyl Ointment, 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)(8)], in that the methods used in, or the
facilities or controls used for, the 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 March 22, 2012, and note that it
lacks sufficient corrective actions.
To read the remainder of this warning letter, click
here.
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