1Equipment and facility
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Inspection Record
BSO, LLC — FDA 483 Findings
Inspectors Lucila B NwatuThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Laboratory and QC controls
The written stability program for drug products does not include specific test methods.
3Process 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.
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 prior to release.
5Equipment 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.
6Documentation and records
The master production and control records are deficient in that they do not include complete manufacturing and control instructions, specifications, special notations and precautions to be followed.
7Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the sterilization process.
8Process validation
Written production and process control procedures are not followed in the execution of production and process control functions.
About this record
Extracted automatically from the document US FDA published on 2025-08-12. 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.
