1Training and personnel
(Personnel) | | | Procedures for training and identifying training needs have not been adequately established.
Inspection Record
Nanchang Anobri Pharmaceutical Co., Ltd. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
(Quality Audit) | | |Procedures for quality audit have not be adequately established.
3Equipment and facility
(Facilities and Equipment System) | | | Procedures for the cleaning and maintenance ofequipment are deficient regarding assignment ofresponsibility for | | }cleaning and maintaining equipment.
4Documentation and records
(Production System) | || | Batch production and control records do not include complete information relating to the production and control of] Jeach batch.
5Other quality system
(Design Control) | Design plans that describe or reference the design and development activities and define responsibility for | implementation have not been established.
6Material and supplier control
(Material System) |1 | I There was a failure to handle and store components at all times in a manner to prevent contamination.
7Laboratory and QC controls
(Laboratory Control System) | | Established test procedures and laboratory control mechanisms are not followed.
8Process validation
(Process Validation) | Procedures for monitoring and control ofprocess parameters for a validated process have not been adequately | } established.
9Laboratory and QC controls
(Laboratory Control System) || | Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures } | rl ‘ .
10Other quality system
(Document Controls) | | | | Document control procedures have not been established and maintained.
About this record
Extracted automatically from the document US FDA published on 2024-10-08. 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.
