1Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing.
Inspection Record
Nature's Pharmacy & Compounding Center — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Training and personnel
Clothing of personnel engaged in th e processing of drug products is not appropriate for the duties they perform.
3Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the to produce aseptic conditions.
4Laboratory 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.
5Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include validation of the sterilization process.
6Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
7Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.
8Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products .
9Equipment and facility
Equipment and utensils are not cleaned, maintained, and sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product .
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.
