1Equipment and facility
The persons double-checking the cleaning and maintenance are not dating and signing or initialing the equipment cleaning and use log.
Inspection Record
McNeil Consumer Healthcare — FDA 483 Findings
Inspectors Anita R. Michael · Matthew R. Noonan · Sharon K. Thoma and 2 moreThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Documentation and records
Each container of component dispensed to manufacturing is not examined by a second person to assure that the weight or measure is correct as stated in the batch records.
3Process validation
Written production and process control procedures are not followed in the execution ofproduction and process control functions.
4Other quality system
Control procedures fail to include adequacy of mixing to assure uniformity and homogeneity.
5Material and supplier control
Each lot of components .was not appropriately identified as to its status in terms of being quarantined, approved or rejected.
6Laboratory and QC controls
Laboratory records do not include complete records of the periodic calibration of laboratory instruments, gauges, and recording devices.
7Equipment and facility
Records are not kept for the maintenance and inspection of eqiIipment.
8Quality unit oversight
Adequate lab facilities for testing and approval or rejection of components and drug products are not available to the quality control unit.
9Material and supplier control
Components are not microscopically examined when appropriate.
10Stability and storage
There is no written testing program designed to assess the stability characteristics ofdrug products.
11Training and personnel
GMP training is not conducted with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.
12Labeling and packaging
Strict control is not exercised over labeling issued for use in drug product labeling operations.
13Complaint and recall handling
Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.
14Laboratory and QC controls
Samples taken ofiu-process materials for determination of conformance to specifications are not representative.
15Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not fully followed.
16Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components and drug products confonn to appropriate standards of identity, strength, quality and purity.
17Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
18Laboratory and QC controls
Written specifications for laboratory controls do not include a description of the sampling procedures used.
19Process 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.
20Process validation
Control procedures are not established which monitor the output and 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.
