Findings
1Computer system validation
Failure to exercise sufficient controls over computerized systems to prevent unauthorized access or changes to data, and failure to establish and follow written procedures for the operation and maintenance of your computerized systems. You have insufficient controls over CGMP data. For example: • You lacked unique passwords for laboratory instruments used to generate analytical data for finished API products. • Your analytical systems lacked controls to prevent users from…
2Complaint and recall handling
Failure of your quality unit to ensure that quality-related complaints are investigated and resolved, and failure to extend investigations to other batches that may have been associated with a specific failure or deviation. Your investigation into a quality-related complaint and out of specification (OOS) results was inadequate. For example, in August 2018, you received a complaint for Potassium Sulfate, USP lot 36830004 due to mold contamination. Retain testing showed a…
3Laboratory and QC controls
Failure to ensure that all test procedures are scientifically sound and appropriate to ensure that your API conform to established standards of quality and purity, and failure to ensure laboratory data is complete and attributable. Your microbial test procedure is inadequate. Your procedure did not include growth promotion studies to verify the adequacy of the media for its intended use. You used microbial growth media prepared in-house and relied only on the original media…
4Cleaning validation
Failure to establish adequate written procedures for cleaning equipment and its release for use in manufacture of API. Your cleaning validation for your non-dedicated manufacturing equipment is inadequate. A. Your quality assurance personnel stated that equipment cleaning is performed between manufacturing campaigns which can vary in length between (b)(4) and (b)(4) and between (b)(4) lots. However, your cleaning validation (18PRO054) did not document or detail the campaign…
About this record
Extracted automatically from the document US FDA published on 2022-07-26. 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.
