<span class="archive__title-prefix>Posts Categorized:</span> Enforcement

FDA Site Selection Model Updated to Include Regional Risk Factors A late-June 2023 update to FDA’s MAPP 5014.1, “Understanding CDER’s Risk-Based Site Selection Model,” adds new factors to how the agency selects which sites to inspect, most importantly, the general compliance history in the country or region where the company under consideration is located. […]

Key point summary: In the June 2023 FDA Report, “Fiscal Year 2022 Report on the State of Pharmaceutical Quality,” from a GMP inspection and compliance perspective, of particular interest are that FDA conducted three times as many surveillance inspections in 2022 as compared to the 115 conducted in 2021, which included 129 inspection classifications under […]

Is it True that Health Regulatory Authorities Do Not Have Access to Internal Audit Reports? Yes and no. It is true that FDA has a policy not to review internal pharma company audit reports during facility inspections, although there are circumstances where the reports must be provided. In the case of FDA, investigators can ask […]

FDA recently posted a 38-page form 483issued toNovel Laboratories, Inc d.b.a. LUPIN,located in Somerset, NJ. The 22-dayinspection of this drug product manufacturer ended on November 5, 2020, and resulted in a total of13 multi-part observations over 38 pages.This has been one of the few on-site inspections performed by the FDA during the COVID-19 health emergency. […]

December is generally a slow time when it comes to posting of FDA Warning Letters. Nevertheless, on Dec. 3, FDA issued a Warning Letter to over-the-counter manufacturer Clientele, Inc. following a Feb. 3-7 inspection of the company’s Sunrise, FL facility. The company’s products generally consist of skincare topicals and cosmetics. Following the inspection, the resulting […]

The week of the U.S. Thanksgiving holiday was yet again another week that was light on Warning Letter enforcement with one GMP letter issued to a drug manufacturer and one untitled letter. The following week saw FDA post a Warning Letter issued to a compounding pharmacy. Drug Warning and Untitled Letters AUROLIFE PHARMA, LLCAurolife Pharma, […]

Of the two drug-related FDA Warning Letters issued last week, one, issued to a homeopathic drug manufacturer in Mexico, identified numerous validation issues concerning the manufacturing process. The other, an untitled letter, was issued to a firm marketing unapproved stem cell products. Drug Warning and Untitled Letters REGENERATIVE CELL INSTITUTE LLC Regenerative Cell Institute LLC […]

FDA posted two drug-related Warning Letters and one untitled letter to a firm marketing a cell-based product. One of the drug Warning Letters concerned a compounding pharmacy. Drug Warning and Untitled Letters YOUNG FOUNDATIONAL HEALTH CENTER, LLC Young Foundational Health Center, LLC (Largo, FL) received an untitled letterfrom CBER based on content of their website […]

Last week, FDA posted two drug-related Warning Letters. One was issued to a drug packager and listed two cleaning validation issues. The other was issued to a manufacturing firm that received a 25-page Form 483 in April. Drug Warning and Untitled Letters KVK-Tech, Inc KVK-Tech, Inc(Newtown, PA) received aWarning Letteron October 8, 2020, based on […]

API issues served as a highlight for one of two Warning Letters issued last week. That one was issued to a drug product manufacturer following a March inspection. The second Warning Letter was sent to a compounding pharmacy. Drug Warning and Untitled Letters RLC Labs Inc RLC Labs Inc(Phoenix, AZ) received aWarning Letteron October 9, […]