1Other quality system
The specification of <Redac ted B4> desi gnated <Redacted B4> is n ot justified with regard to the manufacturing process of <Redacted B 4>.
Inspection Record
ZS Pharma, Inc. — FDA 483 Findings
Inspectors Massoud MotamedThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
The reliability of test method TM-026 to quantitate elemental composition of <Redacted B4> has not been demonstrated.
3Quality unit oversight
Process validation procedures do not ensure the integrity of process validation, and the quality unit does not retain the authority to accept or reject batches conducted in accordance with process validation.
4Computer system validation
Proper controls are not exercised over computerized systems used for analytical testing to ensure drug products meet their specified quality attributes.
5Equipment and facility
Buildings, facilities and equipment are not maintained to ensure the API's identity, strength, qual ity and purity.
6Cleaning validation
Cleaning validation of the equipment used to manufacture APT is not established to ensure that contamination that would alter the safety, identity, strength, quality or purity of the drug product is prevented.
About this record
Extracted automatically from the document US FDA published on 2024-01-17. 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.
