1Stability and storage
Results of stability testing are not used in determining appropriate storage conditions and expiration dates.
Inspection Record
Central Admixture Pharmacy Services Inc — FDA 483 Findings
Inspectors Jolanna A Norton · Doan N Singh · Xiaohui Shen and 1 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
Batch production and control records do not include complete information relating to the production and control of each batch.
3Equipment and facility
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitaiy condition.
4Complaint and recall handling
Procedures describing the handling of written and oral complaints related to drug products are not written or followed and deficiently written or followed.
5Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment to produce aseptic conditions.
6Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure ofa batch or any of its components to meet any of its specifications whether or not the batch has been akeady distributed.
7Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
8Other quality system
Established sampling plans are not documented at the time of performance.
9Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
10Laboratory and QC controls
The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.
11Process validation
Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.
12Process validation
Written production and process control procedures are not followed in the execution ofproduction and process control functions and documented at the time ofperfom1ance.
13Laboratory and QC controls
Laboratory controls do not include the establishment of scientific.ally sound and appropriate specifications and test procedures designed to assure that drug product containers, closures and drug products conform to appropriate standards of identity, strength, quality and purity.
14Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
About this record
Extracted automatically from the document US FDA published on 2024-01-25. 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.
