1Laboratory and QC controls
The accuracy and sensitivity of test methods have not been established.
Inspection Record
Novel Laboratories, Inc. d.b.a LUPIN — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Computer 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.
3Process validation
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
4Stability and storage
The written stability program is not followed.
5Complaint and recall handling
Written procedures are not followed for evaluations done at least <Redacted B4> and including provisions for a review of complaints, recalls, returned or salvaged drug products, and investigations conducted for each drug product.
6Equipment and facility
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained in a good state of repair.
7Deviation, CAPA, and investigation
REPEAT OBSERVATION There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.
8Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products confonn to appropriate standards of identity, strength, quality and purity.
9Equipment and facility
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.
10Labeling and packaging
Employees engaged in the manufacture, processing and packaging of a drug product lack the training required to perform their assigned functions.
11Quality unit oversight
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on the identity, strength, quality and purity of drug products.
12Equipment 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 of a drug product.
13Contamination control
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations.
About this record
Extracted automatically from the document US FDA published on 2021-01-14. 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.
