Wednesday, October 14, 2015

Warning Letter of the Week: "neglecting your job" edition

FDA sends a blistering 483 to Unimark Remedies Ltd. of Mumbai, India late last month, including this little gem:
1.    Failure to document production and analytical testing activities at the time they are performed.

During our inspection, we found that test results and other entries in the production records were not entered while batches were in production.  For example,

a.    The investigator observed [redacted] batch [redacted] production on March 18, 2014. The start and stop times and [redacted] for Step #[redacted] were not recorded or signed in the batch record contemporaneously.

b.    For your [redacted] products returned due to the presence of extraneous threads, the investigator found many inconsistencies in your reprocessing batch records.  Specifically, operators signed batch records for periods when they were not in your facility, indicating these activities were documented by personnel who did not perform them.  During the inspection, and in your written responses, your managers admitted that the batch records were created after the manufacturing process.

c.    Water testing records for sampling point [redacted] on March 19, 2014, were incomplete. Specifically, the analyst did not record observations at the time they were made on March 18, 2014.  Your microbiology records did not identify who prepared the samples, when they began incubation, who read the samples, or when the samples were read.

According to your responses to these FDA 483 observations, your manufacturing staff did not exhibit acceptable documentation practices, and your chemist or microbiologist each neglected his work. (emphasis CJ's) However, your management is responsible for routine oversight of manufacturing and testing operations, including the activities of operators and other personnel, and your responses do not address the failure of management and the flaws in your overall quality system.
That's a quiet day in the company breakroom, I'll bet.  

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