The recently issued and very uncommon Food and Drug Administration notice directing manufacturers and study sponsors to carefully scrutinize third-party generated data serves as timely reminder that the selection of third-party testing laboratories can play a critical role in the FDA submission process. Ensuring that laboratories you choose to work with meet certain and specific criteria is paramount. While the FDA notice is primarily directed to the medical device marketplace, the warning can and should apply to the use of any outsourced testing partner for regulated life science industries.

You may read and review the FDA notice here:

Key content sections of the FDA notice include:

“The FDA is reminding sponsors of device studies and manufacturers of devices to carefully evaluate the third parties they engage to conduct performance testing and to independently verify all testing results before submitting to the FDA. It is the responsibility of device firms to qualify third parties that generate data and to ensure that all information submitted to the FDA is truthful and accurate. In recent years, the FDA has observed that an increasing number of entities that contract with device firms to conduct testing on medical devices (“third-party test labs”) are generating testing data that are fabricated, duplicated from other device submissions, or otherwise unreliable. When such data are submitted to the FDA, the agency is unable to rely on them to grant marketing authorization and it calls into question the data integrity of the entire file. The FDA has identified an increase in submissions containing unreliable data generated by third-party test labs, including from numerous such facilities based in China and India.”

The CS Analytical Team appreciates that when the FDA feels a topic warrants the issuance of an uncommon notice to industry, it is a matter that must be taken with extreme seriousness. It also serves as a reminder to industry of the key criteria that must be scrutinized when selecting a third-party partners to work with. Credentials and Certifications, along with a strong history of client and regulatory authority audits, are key components to ensuring that your partner laboratory is meeting or exceeding industry expected standards. As such, from the onset, the CSA Team built its cGMP quality system to ensure that data integrity is at the foundation of the work we perform. As a USA-based provider of qualification testing for medical product package systems, we routinely generate critical data that is part of client FDA submissions. We have implemented strict quality processes at every step of the testing process that have been reviewed, verified and challenged through numerous client audits and FDA inspections – the most recent in January 2024 with no observations noted. Other critical quality specific credentials include:

Strict Adherence ALCOA+ Principles:

Attributable                          Legible

Contemporaneous              Original

Accurate                              Complete

Consistent                           Enduring


ALCOA+ is a set of principles that ensures data integrity in the life sciences marketplace, and it is a key component that is reviewed and enforced by the FDA (Food & Drug Administration). These principles are applied to a range of areas, particularly in relation to pharmaceutical research, manufacturing and testing. They play a key role in helping to ensure GMP compliance.

To help ensure that the CS Analytical Team meets these critical regulatory required expectations, a number of key quality credentials and certifications are maintained.

CS Analytical is an FDA registered analytical testing laboratory: FEI # 3017927136. Work performed for submission to the FDA is done in compliance with cGMP guidelines (21 CFR Parts 210 & 211) as applicable to a contract analytical testing laboratory. Key components of FDA registration include:

    CA Analytical has implemented current Good Manufacturing Practices (cGMPs) as stated in the code of Federal Regulations. These regulations apply to the facility or controls to be used for the “Manufacture, Processing, Packing or Holding of Drugs;” Although our facility does not perform these functions and are therefore not subject to these practices, we do operate within the following sections of the regulations: 21 CFR Subpart 11; 21 CFR Subpart 210; 21 CFR Subpart 211; 21 CFR Subpart 58; 21 CFR Subpart 820.
    CS Analytical has not been debarred by the FDA nor is currently involved in any debarment proceeding with the FDA. Determined by a signed and dated certification statement, no person employed by the laboratory has currently or in the past five years been convicted of any crime described in Sections 306 (a) or (b) of the Generic Drug Enforcement Act of 1992. It is written per our internal quality system that CS Analytical has not, and will not, use the services of any person debarred under Section 306 of the Generic Drug Enforcement Act of 1992.

In additions, CS Analytical also holds the following certifications:

Controlled Dangerous Substances Schedules 2 through 5:

International Safe Transit Certified Testing Laboratory

The FDA registration along with these key certifications help to ensure that all work performed by the CS Analytical Teams meets or exceeds all regulatory requirements for the clients we serve. Our commitment to quality never wavers regardless of the job at hand. It is this approach and culture that ensures each test request completed meets the robust ALCOA+ requirements of a cGMP operation.