1Equipment 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.
Inspection Record
McNeil Consumer Healthcare — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.
3Laboratory and QC controls
Laboratory records do not include a description ofthe sample received for testing, the source or location from where the sample was obtained, the quanitity of the sample, the date the sample was taken, and the date the sample was received fo r testing.
4Deviation, CAPA, and investigation
Investigations of an unexplained discrepancy did not extend to other drug products that may have been associated with the specific failure or discrepancy.
5Quality unit oversight
The establishment of specifications including any changes thereto, are not reviewed and approved by the quality control unit.
6Labeling and packaging
Strict control is not exercised over labeling issued for use in drug product labeling operations.
7Other quality system
(215) ME AN TITLE OF INOIVIOUA DEPARTMENT OF EEALTH AND HUMAN SERVICES FOOD AND DRUG ADMlNlSTRATION (-----...
8Documentation and records
Batch production and control records do not include complete information relating to the production and control of each batch.
9Material and supplier control
Labeling and packaging materials are not representatively sampled and examined upon receipt and before use in packaging and lab eling of a drug product .
10Complaint and recall handling
Written procedures are not established for evaluations done at least annually and including provisions for a review of c omplaints, returned or salvaged drug products, and investigations conducted for each drug product.
11Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been thoroughly distributed.
12Material and supplier control
Representative samples are not taken of each shipment of each lot of components for testing or examination.
13Other quality system
Evidence of reserve dr ug prod uct sa mple deterioration wa s not investigated.
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.
