1Deviation, CAPA, and investigation
Written records are not made of investigations into unexplained discrepancies.
Inspection Record
California Pharmacy & Compounding Center — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Labeling and packaging
Strict control is not exerc ised over labeling issued for usc in drug product labeling operations.
3Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include validation of the sterilization process.
4Laboratory 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.
5Contamination control
The separate or defined areas and control systems necessary to prevent contamination or mix-ups are deficient.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
7Documentation and records
Procedures for the preparation of master production and control records are not followed.
8Training and personnel
Employees are not given training in the particular operations they perform as part of their function, current good manufacturing practices, and written procedures required by current good manufacturing practice regulations.
9Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
10Equipment 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.
11Aseptic processing and sterility assurance
Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products.
12Labeling and packaging
The labels of your outsourcing facility's drug products do not include information required by section 5038 (a)(10)(A)a nd ( B).
13Aseptic processing and sterility assurance
Each batch of drug product purporting to be sterile is not laboratory tested to determine conformance to such requirements.
14Training and personnel
Clothing of personnel engaged in the manufacturing, processing, and holding of drug products is not appropriate for the duties they perform.
15Stability and storage
Results of stability testi ng are not used in determining expiration dates.
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.
