FDA’s Office of Compliance details enforcement actions in 2021

Regulatory NewsRegulatory News | 02 May 2022 |  By 

The US Food and Drug Administration (FDA) Office of Compliance (OCC) issued numerous enforcement discretion decisions to increase supplies of critically needed medicines for treating COVID-19 and increasingly relied on the use of inspection alternatives, such as product sampling and reviewing firms’ written response to records, instead of traditional onsite inspections in 2021.
These are some of the areas highlighted in OCC’s latest annual report released 2 May, detailing enforcement activities taken last year. Among the specific topics addressed in the report include actions taken against makers of poor-quality compounded drugs, reducing the impact of the opioid crisis, enhancing clinical trial oversight, efforts to implement the Drug Supply Chain Security Act (DSCSA), and initiatives to support global collaborations with other regulators.
In total, OCC issued 140 warning letters across compliance divisions and 101 facility inspection classification letters. The division obtained injunction against two facilities: Premier Pharmacy Lab and Fusion Health and Vitality and issued 26 notice of noncompliance letters and three notices for noncompliance in conducting clinical trials. The OCC also oversaw 138 Class I drug products recalls, 800 drug product recalls in Class II and 100 drug product recalls in Class III.
The agency issued 15 enforcement discretion decisions to increase supplies of COVID medicines in shortage, including albuterol, oxygen, and propofol. OCC, in partnership with the Office of Pharmaceutical Quality (OPQ), conducted manufacturing quality reviews for seven COVID-19 emergency use authorizations (EUAs), including monoclonal antibodies.
FDA issued 28 warning letters to companies for promoting fraudulent products for treating COVID.  Products included topical antiseptics, salt scrubs, nasal antiseptics, herbal oil sprays, mouth rinses and industrial bleach.
In other areas, the report said 57% of the drug adulteration warning letters were based on testing samples, 27% relied on an onsite inspection, 13% were based on a records request,  and 3% were prompted by a refusal to cooperate with FDA for a records request. The agency noted that testing samples “proved to be very effective” in identifying that 84% of hand sanitizers imported from Mexico were not compliant with FDA regulations.
FDA said prior to 2021, the “vast majority” of warning letters for violations of good manufacturing practices (GMPs) were based on onsite inspections. This shifted during the  pandemic, when the agency increasingly relied on alternative tools to inspect facilities, including testing samples at the border and reviewing information submitted by a request for records under 704(a)(4) of the Federal Food Drug and Cosmetic Act, as noted by an FDA official last fall  (RELATED: FDA official says increasing number of enforcement stem from inspection alternatives, Regulatory Focus, 1 November, 2021).
FDA used its records request authority to conduct 45 remote regulatory assessments of sites conducting biomedical research for clinical trials.
To bolster the quality of compounded drugs, FDA last year created a new Office of Compounding Quality and Compliance, which is staffed by compounding experts, pharmacists and chemists. In addition, FDA’s Compounding Quality Center of Excellence celebrated its second anniversary in 2021.
In opioid-related actions, the agency issued warning letters to Umbrella Labs and Cannalfyl, two companies selling fraudulent opioid addition treatments, and issued more than 50 warning letters targeting pharmacies unlawfully selling opioids on the internet.
FDA issued four guidance documents to assist trading partners in complying with DSCSA, including a revised final guidance on identifying suspect products; a revised draft guidance on defining suspect product and illegitimate products; final guidance on product identifiers; and a draft guidance on enhanced drug distribution at the package level (RELATED:  FDA details plans for DSCSA implementation in four guidances, Regulatory Focus, 4 June 2021).
OCC also took action to combat nitrosamines in drug products, first found in mid-2018 in the antacid ranitidine or Zantac. In 2021, the agency issued an alert to health care providers on Pfizer’s voluntary recall of the smoking cessation drug Chantix (varenicline) due to the presence of high nitrosamine levels found in the product.
To enhance global cooperation, OCC’s Office of Scientific Investigations (OSI) shared 54 bioresearch inspection reports and participated in remote bioresearch inspections with global regulators in 2021. Also, for the first time, FDA relied exclusively on a European Medicines Agency (EMA) inspection to support clinical trial data and data reliability for a new drug application.
Future priorities for this year are supporting COVID response efforts, including developing new therapies, taking more steps to reduce the public health crisis posed by opioids and continuing to strengthen oversight of compounded drugs.
OCC annual report


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