About this document
FDA Warning on Inadequate Batch Review by Mina Maher Mikhail is a document available to read on EtoBox.
The FDA issued a Warning Letter to a Chinese API manufacturer for inadequate batch record reviews. The batch production records contained blank or incomplete manufacturing data, lacked dates and signatures for verification, and had sticky notes directing operators to enter data. Additionally, cleaning records and equipment logs were missing dates, signatures, or had blank pages, indicating documentation was not verified in a timely manner. The FDA concluded the quality unit was not fully exercising its auth
- Author
- Mina Maher Mikhail
- Language
- EN