1Documentation and records
Batch production and control records do not include complete information relating to the production and control of each b atch.
Inspection Record
Impax Laboratories, Inc — FDA 483 Findings
Inspectors Walden H. Lee · Kim L. Thomas Cruse · Daniel J. RobertsThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Complaint and recall handling
Written procedures are not followed for evaJuations done at least rumually and including provisions for a review of complaints, recalls ..
3Stability and storage
Drug products are not stored under appropriate conditions of humidity so that their identity, strength, quality, and purity are not affected.11Drug products are not stored under appropriate conditions of humidity so that their identity, strength, quality, and purity are not affected.
4Computer system validation
Appropriate controls are nm exercised over computers or related systems to assure that changes i11 master production and control records or other records are instituted only by authorized personneL Specifically, Pertaining to NDA redacted (b)(4) Levodopa / Carbidopa IPX066 A.
5Material and supplier control
Reports of analysis from component suppliers are accepted in lieu o f testing each component for conformity with all appropriate written specifications, without establishing the reliability of the supplier's analyses through appropriate validatio n of the supplier's test results at appropriate intervals.
6Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure ofa batch or any of its components to meet any of its specificat ions whether or not the batch has been already distributed.
7Laboratory and QC controls
The accuracy, sensitivity, specificity, and reproducibility of test methods have not been established.
8Equipment and facility
Written procedures for cleaning and maintenance fail to include description in sufficient detail of methods, equipment and materials used, description in sufficient detail fo the methods of disassembling and reeassembling equipment is necessary to assure proper cleaning and maintenance and parameters relevant to the operation.
9Other quality system
An annual report did not include a full description of the manufacturing and control changes not requiring a supplemental application, listed by date in the order in which they were implemented.
10Training and personnel
Employees engaged in the manufacture and processing of a drug product lack the training and expe~iencc required to perfonn their assigned functions.
11Other quality system
Procedures describing the warehousing of drug products are not followed.
12Process validation
Control procedures are not established which validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.
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.
