Findings
1Training and personnel
Failure to prepare, review, and approve documents related to the manufacturing of API in accordance with written procedures. You failed to document all CGMP related manufacturing activities at the time they were performed. Our investigator observed numerous unlabeled (b)(4) drums in your manufacturing areas. Your personnel indicated these drums contained (b)(4) from various processes but were unable to identify what products and processes they were associated with. In…
2Quality unit oversight
Failure of your quality unit to exercise its responsibility to ensure the API manufactured at your facility are in compliance with CGMP. Your firm’s quality unit (QU) failed to perform routine QU functions to ensure drug manufacturing operations were adequate. For example, your QU failed to: • Follow your change control procedure for drugs shipped to the United States. You failed to evaluate the use of different (b)(4) in your (b)(4) manufacturing process through your…
3Laboratory 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. Your firm’s stability program was inadequate. Your firm failed to place at least one batch of each API manufactured in 2021, 2022, and 2023 on stability. Additionally, there were no stability chambers nor stability and reserve samples available at your facility. In your…
4Cleaning validation
Failure to adequately validate written procedures for the cleaning and maintenance of equipment. You failed to adequately validate cleaning procedures for your non-dedicated manufacturing equipment to ensure it is fit for its intended use. You also failed to properly maintain your equipment as they were observed to be in a state of disrepair. Your quality assurance personnel stated that your firm has not carried out cleaning validation for non-dedicated manufacturing…
5Laboratory and QC controls
Failure to demonstrate your manufacturing process can reproducibly produce an API that meets its predetermined quality attributes. Also, there is no assurance that your facilities, equipment, and testing methods are suitable for their intended use. Your firm failed to establish a protocol and implement a plan to ensure all API manufacturing processes, equipment and facilities are fit for use. For example, • Your firm could not provide records that process performance…
About this record
Extracted automatically from the document US FDA published on 2024-12-17. 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.
