1Validation and qualification
The number of qualified personnel is inadequate to perform and supervise the processing.
Inspection Record
Essential Pharmacy Compounding LLC — FDA 483 Findings
Inspectors Joseph R. Lambert · Jenny A. Agila SefenThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation ofthe sterilization process.
3Complaint 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.
4Laboratory and QC controls
Laboratory controls do not incl ude a determination of conformance lO appropriate specifications for drug products.
5Equipment 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 Specifically, The contact dwell time for <Redacte d b4>, w hich is utilized as your sporicidal agent in your c lean room, has not been established with support of scientific data.
6Material and supplier control
Each component is not tested for conformity wi th all appropriate wrinen specifications for purity, strength, and quality.
7Training and personnel
Clothing of personnel engaged in the processing of drug products is not appropriate for the duties they per form.
8Stability and storage
There is no written testing program designed to assess the stability characteristics of drug products.
9Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been al ready distributed.
10Material and supplier control
Written procedures are not followed for the receipt, identification, storage, handling, sampling, testing, approval, and rejection of components, drug product containers, and closures.
11Aseptic processing and sterility assurance
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
12Equipment and facility
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition.
About this record
Extracted automatically from the document US FDA published on 2025-06-20. 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.
