Findings
1Laboratory and QC controls
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. You failed to implement an adequate stability program for (b)(4) API. For example, you lacked appropriate stability protocols. You established the current, (b)(4) retest date for (b)(4) API by testing reserve samples from one batch (batch (b)(4) ). This batch was…
2Regulatory reporting and change control
Failure to demonstrate that your manufacturing process can reproducibly manufacture an API meeting its predetermined quality attributes. You failed to validate the manufacturing process for (b)(4) API. You stated you have not validated the manufacturing process for (b)(4) API because the batches are manufactured by customer orders. You made several changes to your manufacturing process without justification or change control. For example, you changed the amounts of (b)(4)…
3Documentation and records
Failure to have a quality unit that is independent of production and fulfills quality assurance (QA) and quality control (QC) duties. Your quality unit (QU) lacked adequate responsibilities and authorities to assure reliable operations. Your QU failed to ensure good documentation practices in your facility as evidenced by: • A Batch Manufacturing Production logbook was found with pages torn out • Numerous signed and partially completed batch records which lacked the…
4Cleaning validation
Failure to ensure that equipment surfaces in contact with API do not alter the quality of the API beyond the official or other established specifications. You failed to ensure the equipment used in the manufacture of API is suitable for its intended use and is properly maintained. For example: • Rust-like residues were observed on product contact surfaces of your equipment labeled as clean, including (b)(4) vessels and hoses. • Tape was used on (b)(4) paddles to prevent…
5Cleaning validation
Failure to adequately validate written procedures for the cleaning and maintenance of equipment and failure to establish adequate written procedures for cleaning equipment and its release for use in manufacture of API. You failed to adequately validate your cleaning process for non-dedicated manufacturing equipment as required by your Validation Master Plan. During the inspection, you did not provide written cleaning procedures for non-dedicated equipment, including your…
About this record
Extracted automatically from the document US FDA published on 2022-02-15. 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.
