1Documentation and records
Batch production and control records do not include the specific identification of each batch of component used for each batch of drug product produced.
Inspection Record
Avella of Deer Valley, Inc — FDA 483 Findings
Inspectors Sonia R. Peterson · Joey V. QuitaniaThe 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
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
3Equipment and facility
Individual equipment logs do not show time, date, product, and lot number of each batch processed.
4Contamination control
Protective apparel is not worn as necessary to protect drug products from contamination.
5Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not.
6Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile do not include validation ofthe sterilization process.
7Deviation, CAPA, and investigation
Written records are not always made of investigations into unexplained discrepancies.
About this record
Extracted automatically from the document US FDA published on 2026-03-23. 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.
