FDA blasts California firm over multiple GLP issues involving non-clinical studies

Regulatory news

| August 11, 2022 | By Joanne S. Eglovitch

The U.S. Food and Drug Administration (FDA) has found a slew of violations of Good Laboratory Practices (GLP) while conducting nonclinical studies in West Sacramento, Calif., Valley Biosystems Company in a letter d warning on August 3 and lambasted the company for not following its own procedures. governing animal welfare, inadequate staff training, data integrity issues and inadequate reporting of non-clinical studies.

The warning letter was sent to the West Sacramento, Calif.-based company over ‘reprehensible conditions’ observed during an inspection from late August to early October that was conducted as part of the monitoring program of the agency’s biological research.

The seven-page warning letter cited the company for five GLP violations.

FDA investigators said the company lacked documentation that staff, including the chairman of the board, three veterinarians, a pathologist and an operations manager, provided the training needed to conduct the study. non-clinical for experimental treatments. “Your company has not kept records of the training your staff have received to adequately assess their skills and qualifications to perform their assigned tasks.”

The company did not follow its own protocol regarding animal welfare. The protocol required that “signs of illness, injury, or animal pain and distress” be reported to the study director and sponsor monitors.” Yet “it has not been documented that these requirements were met” for four sick animals, one suffering from haemorrhagic diarrhea and three animals infected with Trichuris.

The company also failed to retain raw data generated from non-clinical laboratory studies. For example, anesthesia records were missing for 12 of the 48 animals that underwent surgery. According to the company’s Quality Assurance Unit (QAU), the original paper documents were thrown away once they were scanned and electronically saved.

In addition, the company “did not retain any source documentation demonstrating your study director’s compliance with GLP requirements with respect to their conduct of writing final reports” for the studies.

The company was also cited for inadequate reporting of non-clinical lab results. For example, the final report had three documents missing; a daily clinical observation for an animal demonstrating “nervous tapping”; a functional observation battery evaluation or an out-of-cage post-dose evaluation which revealed that the animal had “abnormal dysmetria” and “slight torso crouching during tripedal walking”; and a missing animal health record for an animal suffering from “acute vomiting”.

Additionally, records from the lab the company contracted to perform histopathology and immunohistochemical analysis cited “numerous comments about poor quality and insufficient tissue collections” sent by the company.

For the “week 5” animals, various deficiencies were noted for all of the spinal cords, eye tissues, kidney tissues, heart tissues and laryngeal tissues.

“Various observations” were noted in the tissues of an animal’s unexpected death, including the ureters, salivary gland, adrenal gland, heart, femur/sternum bone, and marrow and kidneys.

For animals sacrificed at 13 weeks, brains were not received from a few animals, and only one liver was received from a group of four animals.

The company has also been lambasted for the QAU’s failure to inspect every lab study to ensure study integrity and keep properly written records.

“Your QAU did not maintain concurrently signed and dated documentation or reports of critical phase inspections. Your QAU stated that critical phase inspection results were written directly on the protocol or on pieces of paper that were thrown away after summarizing the results in monthly QA status reports.”

The company was given 15 days to respond to the letter, and failure to respond may result in regulatory action.

Warning letter

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