Sincerus Florida, LLC — FDA 483 Findings

Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet appropriate statistical quality control criteria as a condition for their approval and release.

Written procedures are not established and followed for the cleaning and maintenance of equipment, including, utensils, used in the manufacture.

The responsibilities and procedures applicable to the quality control unit are not in writing or fully followed.

Procedures designed to prevent objectionable microorganisms in drug products not required to be sterile are not established, written or followed.

Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.

Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.