1Quality unit oversight
The Quality Unit does not review and approve all appropriate quality-related documents.'' Specifically, a.
Inspection Record
Spectrum Laboratory Products — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Cleaning validation
Cleaning procedures are not validated.
3Validation and qualification
There is not an adequate number ofpersonnel qualified by appropriate training to perform and supervise the manufacture ofAPis.
4Documentation and records
02/08-02/10/23, 02/13, 02/15·02/17/23, 02/21-02/24/23,03/06,03/15,03/24/23 755,769 and 777 Jersey ~venue Batch Production and Control Records are not dated and signed when issued.
5Deviation, CAPA, and investigation
Written procedures are not established and followed for investigating critical deviations or the failure ofa batch of APT to meet specifications.
6Deviation, CAPA, and investigation
There is a failure to make sure that aJl critical deviations are investigated and resolved.
7Laboratory and QC controls
Laboratory control records do not include complete data derived from alJ tests conducted to ensure compliance with established specifications and standards, including examinations and assays.
8Documentation and records
Master Production Records do not include detailed production instructions.
9Other quality system
There is a lack ofdefined areas or other control systems for activities within the warehouse.
10Complaint and recall handling
There is a failure to conduct complaint investigations to determine the cause.
11Stability and storage
Failure to conduct stability studies to justify assigned expiration or retest dates ofrepackaged API products in different types ofcontainers/c1osures than that used by the API manufacturer.
12Contamination control
There is a failure to conduct repackaging operations under appropriate environmental conditions to avoid contamination and cross.contamination.
About this record
Extracted automatically from the document US FDA published on 2023-10-05. 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.
