Jabones Pardo S.A..
Product: pharmaceutical manufacturing facility
an investigator from the U.S. 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 products 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.
Our inspection also revealed that your firm failed to fulfill its registration obligations under Section 510(i)(1) of the Act and its listing obligations under Sections 510(i)(2) and 510(j), which is prohibited under Section 301(p). 21 U.S.C. 360(i)(1) and (2), 360(j), and 331(p).
Our investigator(s) observed specific violations during the inspection, including, but not limited to, the following:
Your firm failed to routinely calibrate, inspect, or check according to a written program designed to assure proper performance and to maintain adequate written records of calibration checks and inspections of automatic, mechanical, electronic equipment, or other types of equipment, including computers, used in the manufacture, processing, packing, and holding of a drug product (21 CFR 211.68(a)).
Specifically, your firm failed to establish a validation program for the computer software Microsoft Dynamics used for production, inventory, lot number generation, and laboratory test methods used for raw material, bulk, and finished product test release. Your firm also uses the Microsoft Dynamics program to assist your quality unit for product, document and component control.
In response to this letter, provide your validation plan/protocol for the Microsoft Dynamics system. Include timelines and a schedule of all corrections.
FDA District Office: CDRH