1. Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).
Your quality unit (QU) lacks appropriate responsibility and control over your drug manufacturing operations.
During the inspection, our investigator observed discarded CGMP documents and evidence of uncontrolled shredding of documents. For example, multiple bags of uncontrolled CGMP documents with color coding indicating they were from drug production, quality, and laboratory operations were awaiting shredding. Our investigator also found a blue binder containing CGMP records, including batch records for U.S. drug products, discarded with other records in a 55-gallon drum in your scrap yard. CGMP documents in the binder were dated as recently as January 21, 2019: seven days before our inspection. Your QU did not review or check these documents prior to disposal.
...The uncontrolled destruction of CGMP records, and your lack of adequate documentation practices, raise questions about the effectiveness of your QU and the integrity and accuracy of your CGMP records.
In your response you state the binder of CGMP documents in your scrap yard was “inadvertently come [sic] to scrap yard” and that you were investigating the issue....You hate it when controlled documents end up in a 55-gallon drum in a scrap yard...