Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Failure 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.
Passage 2Failure 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.
Passage 3You 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 example, you rely on studies conducted on development lot sizes for **(b)(4)** API intermediates manufactured utilizing different equipment than that used for commercial production.
Passage 4Failure to have originals or copies of records readily available and promptly retrievable during the retention period.
Passage 5You 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.
Passage 6Failure 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.