Recipient:Cardinal Enterprises, Inc
Product: drug products.
This inspection revealed significant deviations from Current Good Manufacturing Practice (cGMP) Regulations (Title 21, Code of Federal Regulations (21 “CFR), Parts 210 and 211). These deviations cause the drug products manufactured at this facility to be adulterated within the meaning of Section 501(a)(2)(B) of the Federal
Food, Drug, and Cosmetic Act (the Act).
Under Section 501 (a)(2)(B), a drug shall be deemed to be adulterated, if the methods used in, or the facilities or controls used for, its manufacture, processing packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this Act as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess. Many of the violations documented during this inspection are similar to those that have previously been brought to your attention. This indicates a continuing pattern of non-compliance with regulations governing the minimum requirements for current good manufacturing practice for the preparation of drug products.
The deviations include, but are not limited to the following:
Master production and control records are not prepared, dated, and signed by one
person with a full handwritten signature and independently checked, dated and
signed by a second person. Master production records are generated from a
computer as electronic records without any apparent controls to assure authenticity
and integrity [21 CFR 21 1.186(a)?Form FDA Observation 21].
Issuing Office: New England District