MSAT Lab: Inadequate data integrity management since 2013
HIT CHECK
Samsung Biologics, a renowned contract manufacturing organization (CMO) for biopharmaceuticals, is facing a red flag after receiving a 'FORM 483' from the U.S. Food and Drug Administration (FDA). This document has put their CMO business under scrutiny, impacting their reputation as a global industry cornerstone. In this article, we delve into the criticisms outlined in the FORM 483 and evaluate their potential repercussions on the biotech industry.
① Three Mistakes of Samsung Biologics as Seen in the FORM 483 Document
② Inadequate Data Integrity Management in the Previously Unaddressed MSAT Department
Samsung Biologics, a prominent player in the international pharmaceutical and biotech landscape, is now at the center of attention due to its recent receipt of the FDA's 'FORM 483.' Within this critical document, allegations of failing to adhere to fundamental Good Manufacturing Practice (GMP) principles have come to light. The FDA has identified six issues, with data integrity management problems taking the forefront. The initial paragraph within FORM 483 highlights this concern, stating, "The Manufacturing Scientific Analytical Technology (MSAT) laboratory has exhibited inadequate control over data integrity since 2013."
Despite previous internal audits aimed at addressing data integrity issues within the MSAT laboratory, the recent FDA citation raises questions. According to FORM 483, an internal audit conducted between 2021 and 2022 revealed instances of shared administrator passwords and a lack of data backups. Subsequent internal audits identified similar issues, although Corrective Actions and Preventive Actions (CAPA) were applied, they failed to rectify the password-sharing problem, as the document notes, "...with no action taken to address shared administrative passwords."
The concerns regarding data integrity were not limited to the FDA alone. Customers of Samsung Biologics conducted audits on July 6th and September 1st, 2022, raising questions about data management practices within the MSAT laboratory. Notably, the company did not promptly inform its customers about the issues observed in the MSAT laboratory. FORM 483 indicates that these problems were not communicated to customers until a period ranging from October 17th, 2022, to January 16th, 2023.
It is worth noting that the issues outlined in FORM 483 related to the MSAT department seem to be distinct from the executive reshuffling that occurred in the second quarter of this year. During that time, a comprehensive investigation was carried out in response to customer claims, leading to suspicions of data manipulation. Consequently, the group leader and team leader of the MSAT department were removed from their positions, and Executive Vice President Sang-Yoon Lee retired from his role.
An unnamed high-ranking official from a South Korean pharmaceutical and biotech company suggested that the recent issues could be attributed to human errors. They pointed out that the departure of senior staff from the quality department resulted in a shortage of personnel with expertise in overseeing FDA inspections and a deep understanding of the company's history, potentially contributing to the basic issues raised by the FDA.
In response to FORM 483, Samsung Biologics has officially clarified that there are no significant process flaws or insurmountable problems, emphasizing that this issue does not affect product quality or patient safety.
Official FDA FAQ Regarding ‘FORM 483’
Q: When is an FDA Form 483 issued?
A: An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. FDA investigators are trained to ensure that each observation noted on the FDA Form 483 is clear, specific and significant. Observations are made when in the investigator’s judgment, conditions or practices observed would indicate that any food, drug, device or cosmetic has been adulterated or is being prepared, packed, or held under conditions whereby it may become adulterated or rendered injurious to health.
Q: What is the purpose of an FDA Form 483?
A: The FDA Form 483 notifies the company’s management of objectionable conditions. At the conclusion of an inspection, the FDA Form 483 is presented and discussed with the company’s senior management. Companies are encouraged to respond to the FDA Form 483 in writing with their corrective action plan and then implement that corrective action plan expeditiously.
Q: Is the FDA Form 483 intended to be an all-inclusive list of every possible deviation from law and regulation?
A: No, it’s not. The FDA Form 483 is a report which does not include observations of questionable or unknown significance at the time of the inspection. There may be other objectionable conditions that exist at the firm that are not cited on the FDA Form 483. FDA investigators are instructed to note only what they saw during the course of the inspection. Companies are responsible to take corrective action to address the cited objectionable conditions and any related non-cited objectionable conditions that might exist.
Q: What are the implications of the FDA Form 483 for agency enforcement and what happens next?
A: The FDA Form 483 does not constitute a final Agency determination of whether any condition is in violation of the FD&C Act or any of its relevant regulations. The FDA Form 483 is considered, along with a written report called an Establishment Inspection Report, all evidence or documentation collected on-site, and any responses made by the company. The Agency considers all of this information and then determines what further action, if any, is appropriate to protect public health.
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