1Process validation
Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance.
Inspection Record
Jones Drug Company Inc. dba Reed’s Compounding Pharmacy — FDA 483 Findings
Inspectors Liming Zhang · Alan P. KurtzbergThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Training and personnel
Clothing of personnel engaged in the processing of drug products is not appropriate for the duties they perform.
3Equipment and facility
Written procedures are lacking for the use of insecticides designed to prevent the contamination of equipment and drug products.
4Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
5Equipment and facility
The flow of components though the building is not designed to prevent contamination.
6Equipment and facility
Routine calibration of automatic and electronic equipment is not performed according to a written program designed to assure proper performance.
7Deviation, 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.
8Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
9Documentation and records
Batch production and control records do not include a description of drug product containers and closures used for each batch of drug product produced.
10Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
11Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile do not include adequate validation of the sterilization process.
12Laboratory and QC controls
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.
13Contamination control
The separate or defined areas necessary to prevent contamination or mix-ups are deficient.
14Documentation and records
Batch production and control records for each batch of drug product produced do not include an accurate reproduction of the appropriate master production or control record which was checked for accuracy, dated and signed.
15Training and personnel
Employees are not given training in the particular operations they perform as part of their function.
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.
