1Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdmg products purp01ting to be sterile did not include adequate validation of the aseptic process.
Inspection Record
Excel Vision — FDA 483 Findings
Inspectors Karen A Briggs · Justin A Boyd · Khoa Nathan V TranThe 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 cleaning and disinfecting the room and equipment to produce aseptic conditions.
3Aseptic processing and sterility assurance
Procedures designed to prevent microbiological contamination ofdmg products purp01ting to be sterile are not established.
4Deviation, CAPA, and investigation
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any ofits components to meet any ofits specifications whether or not the batch has been already distiibuted.
5Other quality system
Written procedures ai·e not followed for evaluations conducted at least aimually to review records associated with a representative number ofbatches, whether approved or rejected.
6Computer system validation
Approp1iate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records ai·e instituted only by authorized personnel.
7Equipment and facility
Records ai·e not kept for the maintenance and inspection ofequipment.
8Process validation
Written procedures are not established that describe the in-process controls and examinations to be conducted on approp1iate samples ofin-process materials ofeach batch.
9Aseptic processing and sterility assurance
Aseptic processing ai·eas are deficient in that floors, walls and ceilings ai·e not smooth and/or hard swfaces that ai·e easily cleanable.
10Aseptic processing and sterility assurance
Aseptic processing ai·eas are deficient regarding the system for monitoring environmental conditions.
About this record
Extracted automatically from the document US FDA published on 2026-05-15. 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.
