1Stability and storage
An adequate number of batches of each drug product are not tested nor are records ofsuch data maintained to determine an appropriate expiration date.
Inspection Record
Pine Pharmacy and Home Care Products Center, Inc. — FDA 483 Findings
Inspectors James A. LiubicichThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug prodncts purporting to be sterile do not include validation of the sterilization process.
3Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
4Contamination control
The separate or defined areas necessary to prevent contamination or mix-ups are deficient .
5Quality unit oversight
Adequate Jab facilities for testing and approval or rejection ofdrug products are not available to the quality control unit.
6Contamination control
occurs Adequate exhaust systems or other systems to control contaminants are lacking in areas where air contamination occurs during production.
7Equipment and facility
Equipment and utensils are not sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
8Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not established.
9Equipment and facility
Equipment used in the manufacture, processing, packing or holding of drug products is not ofappropriate design to facilitate operations for its intended use and cleaning and maintenance.
10Training and personnel
Clothing of personnel engaged in the processing o fdmg products is not appropriate for the duties they perform.
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.
