Findings
1Process validation
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 prior to release and distribution of your API. Specifically, you manufactured and distributed two batches of semaglutide API to the U.S. market despite having conducted no…
2Laboratory and QC controls
Failure to ensure that all specifications and test procedures are scientifically sound and appropriate to ensure that your APIs conform to established standards of quality and purity. You failed to establish that your analytical test methods are appropriately validated and suitable for use in API release testing. For example, in 2024 your firm shipped (b)(4) lots of tirzepatide API (about (b)(4) total weight) to the U.S. market without completing analytical method validation…
3Quality unit oversight
Failure of your quality unit to exercise its responsibility to ensure that APIs manufactured at your facility are in compliance with CGMP and failure to maintain complete traceability of APIs in commercial distribution. Your firm is a manufacturer of peptide APIs, including Glucagon-Like Peptide-1 (GLP-1) Receptor Agonist APIs. FDA investigators observed that your firm lacked adequate quality unit (QU) oversight for the receipt of materials, repackaging, relabeling, and…
4Aseptic processing and sterility assurance
Failure to ensure that water used in the (b)(4) manufacturing steps of a non-sterile API intended for a sterile drug product is monitored and controlled for total microbial counts, objectionable organisms, and endotoxins. You manufacture GLP-1 APIs that were imported into the United States. These GLP-1 APIs are intended for use in sterile injectable drug products. Your firm failed to ensure that the (b)(4) water you used in the (b)(4) manufacturing steps of your APIs was…
About this record
Extracted automatically from the document US FDA published on 2026-05-19. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
