FDA Warning Letter: There is no assurance that you maintain complete electronic raw data for laboratory instruments and data acquisition software (ucm455345)


Ofni Systems

“Failure to record activities at the time they are performed and destruction of original records.

Specifically, your employees completed batch production records entries days after operations had ended, released lots before the proper approvals, and failed to maintain original manufacturing data for critical steps in the batch production records.  For example,

a) Our investigators found that some of your operators used “rough notes” (unbound, uncontrolled loose paper) to capture critical manufacturing data and then destroyed these original records after transcription into the batch production records. For example, the [redacted] chemist recorded original manufacturing data as rough notes and left these rough notes for the [redacted] chemist to transcribe into the batch production records.  The next morning, the [redacted] chemist signed the batch production records and destroyed the original rough notes.  We interviewed employees during the inspection who confirmed your firm’s practice of transcribing data to batch records and destroying original records

b) Additionally, our investigators found backdated batch production records dated February 10 to February 25, 2014, signed by your Production Manager and Technical Director in the “Batch Manufacturing Record Reviwed [sic] by” section. The Technical Director stated that he was not in the facility on these dates and was “countersigning” for another person who allegedly performed these review activities.  However, these records did not contain signatures (contemporaneous or otherwise) of the alternate reviewer who purportedly conducted the review. Furthermore, the Technical Director backdated his own signature to the date the quality unit (QU) reviewed and released your drug product.  His backdated signatures are on [redacted] batch records for lots [redacted]; and [redacted] batch records for lots [redacted].  You released these batches before the Technical Director returned to the facility and backdated his signatures.  The batch records, therefore, do not demonstrate that you completed your required review before releasing your products…

Failure to prevent unauthorized access or changes to data, and to provide adequate controls to prevent omission of data.

Your laboratory systems lacked access controls to prevent raw data from being deleted or altered. For example,

a) There is no assurance that you maintain complete electronic raw data for your Gas Chromatography (GC) instrument. FDA investigators observed multiple copies of raw data files in the recycle bin connected to the GC instrument QC-04 even in the presence of “Do Not Delete Any Data” notes posted on two laboratory workstation computer monitors.

b) Employees were allowed uncontrolled access to operating systems and data acquisition software tracking residual solvent, and test and moisture content. Our investigators noted that there was no password functionality to log into the operating system or the data acquisition software for the GC, the High Performance Liquid Chromatography (HPLC) instrument QC-17, or the Karl Fischer (KF) Titrator QC-13.

c) HPLC SpinChrome and GC Lab Station data acquisition software lacked active audit trail functions to record changes in data, including original results, who made changes, and when.

In your response, you state that your laboratory GC, HPLC and KF systems are now password-protected and that you have begun drafting analytical software password procedures for the GC, HPLC and KF laboratory instruments.  However, your response does not state whether every analyst will have their own user identification and password.  You also mention plans to install a validated computer system.  However, you did not provide a detailed corrective action and preventive action (CAPA) plan or conduct a review of the reliability of your historical data to ensure the quality of your products distributed to the U.S. market.

Inadequate controls of your computerized analytical systems raise questions about the authenticity and reliability of your data and the quality of your APIs.  It is essential that your firm implements controls to prevent data omissions or alterations.  It is critical that these controls record changes to existing data, such as the individuals making changes, the dates, and the reason for changes.

In response to this letter, provide your comprehensive CAPA plan for ensuring that electronic data generated in your manufacturing operations, including laboratory testing, cannot be deleted or altered.  Also identify your quality control laboratory equipment and any other manufacturing-related equipment that may be affected by inadequate controls to prevent data manipulation.

View the original warning letter.

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