1Equipment and facility
Records are not kept for the cleaning of equipment.
Inspection Record
Accura-Pac, Inc. — FDA 483 Findings
Inspectors Amatul H MariumThe inspectors who signed the published document.Inspector lookup
View the regulator's official source The source document is always the basis for judgement.
Findings
2Process 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.
3Computer system validation
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
4Stability and storage
All compounding and storage containers used during the production of a batch of drug product is not properly identified at all times to indicate contents.
5Material and supplier control
Written procedures are not followed for the approval of components.
About this record
Extracted automatically from the document US FDA published on 2026-07-16. 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.
