Findings
1Documentation and records
Failure of your quality unit to exercise its responsibility to ensure the intermediates manufactured at your facility are in compliance with CGMP. Several original batch production records were found torn in your scrapyard. The investigator asked to review the batch records associated with the torn documents. Your management then provided a second set of these batch records in question. During the inspection, no explanation was provided regarding how there could be two sets…
2Complaint and recall handling
Failure of your quality unit to ensure that quality-related complaints are investigated and resolved. You failed to adequately investigate a complaint of (b)(4) particles in the intermediate, (b)(4) , Stage- (b)(4) , batch (b)(4) . The root cause was attributed to improper cleaning/usage of the (b)(4) bag. A CAPA to change the (b)(4) bag more frequently (i.e., after (b)(4) batches instead of (b)(4) batches) was proposed. The complaint investigation was deficient because it…
3Cleaning validation
Failure to clean equipment and utensils to prevent contamination or carry-over of a material that would alter the quality of the intermediates beyond the official or other established specifications. You failed to have adequate procedures for the cleaning and maintenance of manufacturing equipment and facilities. Our inspection found manufacturing equipment labeled as “Cleaned” and found the following deficiencies. For example: • (b)(4) #B- (b)(4) -404 in Production Block-…
About this record
Extracted automatically from the document US FDA published on 2025-03-11. 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.
