1. Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188).
Compression machine process control values were not adequately reported in your batch production records during the manufacture of [redacted]mg tablets intended for the U.S. market. Your quality unit used these deficient records to release batches of this drug product.
While multiple batch records of [redacted]mg tablet included handwritten values routinely within process parameters, the values recorded by the programmable logic controller (PLC) of your compression machine were frequently outside your established process parameters. For example, [redacted]mg batch [redacted]had compression force values handwritten [redacted]in the batch record ranging from [redacted](your limit was (b)(4)).
However, the PLC data recorded individual values ranging from [redacted]for the same time period. In addition to compression force values, handwritten values for filling depth and automatic weight control (AWC) did not accurately reflect the values within the PLC data.
An inspection conducted by the [redacted]in March 2018 found similar discrepancies between the compression force values in batch records and PLC data.