Findings
1Other quality system
Failure to demonstrate that your manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes. Your response to our request for records or other information pursuant to section 704(a)(4) indicates that you manufactured and distributed (b)(4) USP API to the United States (U.S.) without validating processes determined to be critical to the quality and purity of the API. For example, in response to our April 16, 2020, request to provide…
2Cleaning validation
Failure to adequately validate written procedures for the cleaning and maintenance of equipment. Your process of cleaning shared API manufacturing equipment is not validated. For example, in response to our April 16, 2020, communication requesting the most recent cleaning validation summary reports for equipment used to manufacture API distributed to the U.S., you indicated that this information was not available and you did not perform cleaning validation. Our subsequent…
3Equipment and facility
Failure to adequately perform qualification of critical equipment and ancillary systems. You have not conducted qualification of critical manufacturing equipment. For example, in response to our April 16, 2020, communication requesting qualification documentation for the equipment used to manufacture API distributed to the U.S., you indicated that you did not perform equipment qualification and thus could not provide any documents. Our subsequent communication on June 1…
4Material and supplier control
Failure to test the identity of each batch of incoming production material. Your incoming raw material used to manufacture API intended for the U.S. market was not adequately tested. For example, in response to our April 16, 2020, communication asking whether you perform at least one specific identity test on each lot of each component, you indicated that an identity test is not performed due to the lack of resources. Such testing is critical to ensure the identity of each…
About this record
Extracted automatically from the document US FDA published on 2021-04-13. 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.
