1Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.
Inspection Record
Pharm D Solutions, LLC — FDA 483 Findings
Inspectors Tracy K Li · Eileen A LiuThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Material and supplier control
Procedures designed to assure that corrects labels, labeling and packaging materials are used for drug products are not written and followed.
3Documentation and records
Batch production and control records do not include complete labeling control records, including specimens or copies of all labeling used for each batch of drug product produced.
4Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance the final specifications and identity and strength length of each active ingredient prior to release.
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.
6Training and personnel
Clothing of personnel engaged in the manufacturing and processing of drug products is not appropriate for the duties they perform.
7Regulatory reporting and change control
Your outsourcing facility did not submit a report to FDA identifying the drugs compounded during the previous six month period.
8Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purpporting to be sterile are not established, written and followed.
9Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include validation of the sterilization process.
10Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
11Material and supplier control
There is a failure to thoroughly review any lmexplained 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.
12Labeling and packaging
The labels of your outsourcing facility's drug products are deficient.
13Aseptic processing and sterility assurance
Each batch of drug product pruporting to be sterile is not laboratory tested to determine conformance to such requirements.
14Process validation
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.
15Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products .
About this record
Extracted automatically from the document US FDA published on 2019-04-30. 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.
