1Equipment and facility
Written records of major equipment maintenance are not included in individual equipment logs.
Inspection Record
L. Perrigo Co — FDA 483 Findings
Inspectors Patsy J Domingo · Martha Sullivan Myrick · Rebecca E. DombrowskiThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Equipment and facility
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
3Material and supplier control
Representative samples are not taken of each shipment of each lot of components for testing or examination.
4Stability and storage
The written stability testing program is not followed.
5Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
6Stability and storage
Results of stability testing are not used in determining expiration dates.
7Deviation, CAPA, and investigation
Deviations from written production and process control procedures are not justified.
8Laboratory 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.
9Documentation and records
Batch production and control records do not include complete information relating to the production and control of each batch.
10Training and personnel
Employees are not given training in the particular operations they perform as part of their function.
11Equipment and facility
Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.
12Equipment and facility
The entries in the equipment cleaning and use logs are not in chronological order.
13Process validation
Written production and process control procedures are not followed in the execution of production and process control functions.
14Deviation, CAPA, and investigation
Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and follow-up.
15Deviation, 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 of its specifications whether or not the batch has been already distributed.
16Equipment and facility
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
17Deviation, CAPA, and investigation
Investigations of a failure of a batch or any of its components to meet any of its specifications did not extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy.
18Other quality system
Established sampling plans are not followed.
19Complaint and recall handling
Complaint records are deficient in that they do not include the known reply to complainant.
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.
