1Documentation 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.
Inspection Record
Specialty Compounding, LLC — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
3Complaint and recall handling
Complaint records are deficient in that they do not include the findings of the investigation and follow-up.
4Laboratory and QC controls
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications and identity and strength of each active ingredient prior to release.
5Material and supplier control
Records fail to include an individual inventory record of each component, reconciliation of the use of each component, and drug product container with sufficient information to allow determination of any associated batch or lot of drug product.
6Documentation and records
Batch production and control records do not include complete information relating to the production and control of each batch.
7Complaint and recall handling
Written complaint records do not include, where known, the name and strength of the drug product, lot number, name of complainant, nature of complaint, and reply to complainant.
8Process 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.
9Equipment and facility
Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
10Aseptic processing and sterility assurance
Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to such requirements.
11Deviation, 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 bas been already distributed.
12Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
13Quality unit oversight
Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.
14Training and personnel
Clothing of personnel engaged in the processing of drug 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.
