Aspen Biopharma Labs Private Limited — FDA Warning Letter Findings

Failure to demonstrate that your manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes and failure to adequately validate written procedures for the cleaning and maintenance of equipment. Process Validation You failed to appropriately validate your processes and adequately qualify the equipment used to manufacture your drugs. Specifically, you have not completed process validation for commercial size lots of your APIs. For…

Failure to design a documented, on-going stability testing program to monitor the stability characteristics of API and to use the results to confirm appropriate storage conditions and retest or expiry dates. Your firm’s stability program is inadequate. For example, your firm does not have adequate data to support the retest date for drugs shipped to the United States. In your response, you acknowledge the deficiencies of your stability program and propose corrective actions…

Failure to design and construct buildings and facilities used in the manufacture of your API in a manner to minimize potential contamination, facilitate appropriate cleaning, maintenance, and operations. You produce higher-risk APIs in an inadequate facility including one that lacks appropriate separation for high pharmacological activity or toxic materials including (b)(4) drugs. During the inspection, our investigator observed your facility was in a state of disrepair…

Failure to have originals or copies of records readily available and promptly retrievable during the retention period. You failed to ensure adequate document control over paper and electronic records. For example, you provided a written statement on firm letterhead admitting to backdating a QC lab document and you signed a declaration confirming commercial drugs shipped to the US were not supported by appropriate original data. In your response, you acknowledge a lack of…