Drugs

Contract Testing Lab Hit with Warning Letter

A 5/3-19 FDA inspection of contract testing laboratory Missouri Analytical Laboratories has led to a just-posted 9/30 Warning Letter that cited significant GMP violations for finished pharmaceuticals and active pharmaceutical ingredients. For example, FDA said the firm failed to thoroughly investigate unexplained discrepancies and out-of-specification (OOS) results. Investigations were also closed without adequate scientific justification.

The letter also said Missouri Analytical failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records. And the firm failed to document and explain deviations and investigate all critical deviations. For example, FDA said the lab obtained an initial OOS result that was attributed to an unknown laboratory error. It then “relied on resampling and retesting to invalidate the original OOS results without identifying a scientifically justified root cause,” FDA said.

Additionally, FDA took exception with Missouri Analytical’s quality system and its oversight of data integrity. The agency acknowledged that a consultant is working with the company to audit its operations and assist in meeting FDA requirements. It asked the firm and its consultant to conduct a “comprehensive investigation into the extent of the inaccuracies in data records and reporting.” It further asked that the investigation include:

A detailed investigation protocol and methodology; a summary of all systems to be covered by the assessment; and a justification for any part of the operation that is excluded.
Interviews of current and former employees to identify the nature, scope, and root cause of data inaccuracies.
An assessment of the extent of data integrity deficiencies at the facility. Identify omissions, alterations, deletions, record destruction, non-contemporaneous record completion, and other deficiencies. Describe all parts of the facility’s operations in which data integrity lapses were discovered.
A comprehensive retrospective evaluation of the nature of the testing data integrity deficiencies. FDA recommended that a qualified third party with specific expertise in the area where potential breaches were identified should evaluate all data integrity lapses.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome