1Material and supplier control
Procedures and controls designed to prevent microbiological contamination of the drug substance intermediate and related components are not established.
Inspection Record
Immunomedics Inc. — FDA 483 Findings
View the regulator's official source The source document is always the basis for judgement.
Findings
2Other quality system
Procedural controls are inadequate to assure the validated state is maintained.
3Quality unit oversight
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.
4Stability and storage
Analytical method verification studies were not performed for the following procedures used during the lot release and stability testing o~(b) <4> 1at Immunomedics Inc.: a.
5Equipment and facility
lYPE ESTABUSHNENT INSPECTED Drug Substance Intermediate Manufacturer Facilities and equipment are not adequately maintained and inspected.
6Other quality system
The~~ process for bioreactors is a semi-automated process, with enhanced control and monitoring ofthJbl < 4l process perfonned by protocol and~b) (4) J positioned near (b) (4) According to the protocol, at any point during the cycle, if it is observed that the minimum(b) (4) is_not beine: oblained unstrer manufacturing will check manual hand valve positions and(b) <4l mes.
7Other quality system
E~SIGW.TURE EMPLOVEE(SJ NAME AND T1Tl£ (PIW or Typo) OAlEISSVEO Wayne E.
8Other quality system
Standard operating procedures are inadequate and/or not followed.
9Equipment and facility
The~b) <4l !Automated Cell Thawing System equipment ID: E00501 and E00502 in thJCb) <4ll (b) <4l jarea are not properly qualified to comply with their intended performance.
About this record
Extracted automatically from the document US FDA published on 2020-04-02. 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.
