1Equipment and facility
Equipment used in the manufacture, processing, packing, or holding of drug products is not ofappropriate design to facilitate operations for its intended use.
Inspection Record
Novel Laboratories Inc. d.b.a. Lupin Somerset — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards and test procedures designed to assure that components conform to appropriate standards of identity,
3Computer system validation
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
4Other quality system
Input to and output' from the computer and records or data are not checked· for accuracy.
5Complaint and recall handling
Procedures describing the handling of all written and oral complaints regarding a drug product are not written and followed.
6Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
7Equipment and facility
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, or holding ofa drug product.
8Equipment and facility
Routine calibration, inspection and checking ofequipment is not performed according to a written program designed to assure proper performance.
9Laboratory and QC controls
Laboratory records do not include complete data derived from all tests, examinations, and assay necessary to assure compliance with established specifications and standards.
10Training and personnel
Employees engaged in the manufacture, processing and packing of a drug product Jack the training required to perfonn their assigned functions.
11Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any ofits specifications whether or not the batch has been already distributed.
12Laboratory and QC controls
The written stability program for drug products does not include reliable, meaningful, and specific test methods.
About this record
Extracted automatically from the document US FDA published on 2022-05-16. 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.
