FDA Issues Final Debarment Order Against Angela Anatilde Baquero for Felony Related to Drug Product Development
Last updated 2026-08-04 · Source: FDA
Primary source: FDA: FDA Issues Final Debarment Order Against Angela Anatilde Baquero for Felony Related to Drug Product Development
The Food and Drug Administration (FDA) has issued a final order permanently debarring Angela Anatilde Baquero from providing services in any capacity to persons with approved or pending drug product applications. This action stems from Ms. Baquero's conviction for a felony under Federal law related to the development or approval of a drug product. The debarment order became applicable on August 3, 2026, after Ms. Baquero waived her right to a hearing.
What this means for your practice
This FDA debarment order underscores the agency's vigilance in maintaining integrity within the drug development and approval process. For telehealth brands, medspas, dental practices, chiropractic offices, and other healthcare businesses, this serves as a critical reminder of the importance of robust due diligence in hiring and contracting. While your practice may not directly develop drug products, engaging individuals or entities that have been debarred by the FDA, even in seemingly unrelated capacities, can expose your organization to significant regulatory risk. Any professional providing services to your practice, particularly those with a history in the broader healthcare or pharmaceutical sectors, should be screened to ensure they are not subject to such exclusions. Adherence to these regulatory principles helps safeguard your practice's compliance standing and reputation.
Rockville, MD – The U.S. Food and Drug Administration (FDA) has announced a final debarment order against Angela Anatilde Baquero, permanently prohibiting her from providing services to any entity that possesses an approved or pending drug product application. This action, applicable as of August 3, 2026, is a direct consequence of Ms. Baquero's conviction for a felony under Federal law, specifically for conduct related to the development or approval of a drug product.
Regulatory Background and Basis for Debarment
The FDA's authority to issue such debarment orders is established under Section 306(a)(2)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act, 21 U.S.C. 335a(a)(2)(A)). This provision mandates the debarment of an individual from providing services to persons with approved or pending drug product applications if that individual has been convicted of a felony under Federal law related to the development or approval, including the process for development or approval, of any drug product.
The agency initiated the debarment process by providing Ms. Baquero with official notice of the proposed debarment and an opportunity to request a hearing to contest the action. Regulations prescribe a specific timeframe for individuals to respond to such notices. In this instance, Ms. Baquero did not respond or request a hearing within 30 days of receiving the notice, specifically by May 6, 2026. Her failure to respond is legally considered a waiver of her right to a hearing concerning this matter, leading directly to the finalization of the debarment order.
Scope of the Debarment
The order permanently debarrs Angela Anatilde Baquero from providing services in *any capacity* to a person that has an approved or pending drug product application. This broad scope means that Ms. Baquero is prohibited from engaging in any work, whether direct or indirect, for organizations involved in the pharmaceutical industry that hold or are seeking drug product approvals. The intent is to protect the integrity and reliability of the drug development and approval process by preventing individuals convicted of relevant felonies from participating in it.
Implications for Individuals and Entities
While this specific debarment order pertains to an individual, it highlights the stringent regulatory environment surrounding drug products and the serious consequences for felony convictions in this area. Individuals subject to debarment are effectively removed from an entire sector of the healthcare industry. The FDA maintains publicly accessible information regarding debarment actions, serving as a critical resource for companies to conduct due diligence.
Potential for Special Termination
The FD&C Act does provide a pathway for individuals to seek special termination of debarment under section 306(d)(4). An application for special termination may be submitted to the FDA at any time through either the Federal eRulemaking Portal (https://www.regulations.gov) or via written/paper submission to the Dockets Management Staff. Applicants must include Docket No. FDA-2026-N-1536 with their submission.
The FDA emphasizes specific instructions for submitting applications, particularly regarding confidential information. While electronic submissions will be posted publicly in their entirety, individuals wishing to submit confidential information must use the written/paper submission method, providing both a confidential and a redacted public copy.
Regulatory Vigilance
This final debarment order serves as a clear indicator of the FDA's commitment to enforcing federal laws governing drug products and maintaining public trust in the drug approval process. It reinforces the necessity for all individuals and entities operating within the broader healthcare ecosystem to adhere to federal regulations and ethical standards.
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Key Facts
| Detail | Value | |---|---| | Debarred Individual | Angela Anatilde Baquero | | Reason for Debarment | Conviction of a felony under Federal law for conduct relating to the development or approval of any drug product | | Effective Date | August 3, 2026 | | Duration of Debarment | Permanent | | Scope of Debarment | Prohibited from providing services in any capacity to a person that has an approved or pending drug product application | | Docket Number | FDA-2026-N-1536 |
Frequently Asked Questions
What does it mean to be debarred by the FDA?
Being debarred by the FDA, in this context, means an individual is permanently prohibited from providing services in any capacity to a person or entity that has an approved or pending drug product application.
Why was Angela Anatilde Baquero debarred?
Ms. Baquero was debarred because she was convicted of a felony under Federal law for conduct relating to the development or approval, including the process for development or approval, of any drug product.
Does a debarred individual have the opportunity to challenge the debarment?
Yes, individuals are given notice of the proposed debarment and an opportunity to request a hearing. However, failure to respond within the prescribed timeframe, as in this case, constitutes a waiver of that right.
Can a debarment order ever be terminated?
Yes, the FD&C Act includes provisions for a special termination of debarment under section 306(d)(4). An application for such termination can be submitted to the FDA.
How can I submit an application for special termination of debarment?
Applications can be submitted electronically via the Federal eRulemaking Portal (regulations.gov) or as written/paper submissions to the Dockets Management Staff. All applications must include Docket No. FDA-2026-N-1536.
Source: FDA — Notice: Angela Anatilde Baquero: Final Debarment Order · 2026-08-03