Firm Record
Bentley Laboratories LLC findings history
11 findings from 2 inspection documents published by regulators. Each row below says what its date means.
Areas cited
Process validationEquipment and facilityLaboratory and QC controlsMaterial and supplier controlDeviation, CAPA, and investigationComputer system validationQuality unit oversight
Published inspection documents
2026-09-29
US FDA
3 findingsMaterial and supplier control · Process validation CFR 201.66(b)(2) defines “active ingredient” to mean “any component that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body of humans.” Although the product label does not specifically list Glycolic Acid as an active ingredient in the Drug Facts labeling, your product labeling makes claims such as “1.5% Glycolic Acid…Clears Skin Fast…Prevents New Breakouts” which demonstrates that this is an “active ingredient” in your acne treatment product because it is intended to furnish pharmacological activity. Specifically, the ingredient for this product is not permitted or recognized as an acceptable active ingredient when used under M006. We note that while salicylic acid is a permitted active ingredient under M006, it is not permitted in combination with the above ingredient or other active ingredients. In addition, as labeled, "Perricone MD Acne Relief Maximum Strength Spot Gel" includes the active ingredients Lactic & Succinic Acids, Citrulline, and Tea Tree Oil, which are not permitted active ingredients under M006.10. Although the product label does not specifically list Lactic & Succinic Acids, Citrulline, and Tea Tree Oil as active ingredients in the Drug Facts panel. Label claims such as “KEY INGREDIENTS Lactic & Succinic Acids: Target Acne-Causing Bacteria…help minimize blemishes…Citrulline: Fight & Visibly Reduce Redness…Tea Tree Oil: helps soothe the skin & visibly reduce redness” demonstrate that these are “active ingredients” in your acne treatment product because they are intended to furnish pharmacological activity. Thus, the “Geologie Acne Control Body Wash” and “Perricone MD Acne Relief Maximum Strength Spot Gel” products do not comply with the applicable conditions specified in M006 and have not otherwise been found to be GRASE. 2 Accordingly, these products are new drugs within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), and there is no basis under section 505G of the FD&C Act under which these products would be legally marketed without an approved application. Because there are no applications in effect for these products, these products are unapproved new drugs. The introduction or delivery for introduction of these unapproved new drug products into interstate commerce violates sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C. 355(a) and 331(d). Misbranded Drug Violations Your “Geologie Acne Control Body Wash” and “Perricone MD Acne Relief Maximum Strength Spot Gel” are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee), because these products are nonprescription drugs subject to section 505G of the FD&C Act, 21 U.S.C. 355h, but do not comply with the requirements for marketing under that section and are not the subject of an application approved under section 505 of the FD&C Act, 21 U.S.C. 355. The introduction or delivery for introduction of a misbranded drug into interstate commerce violates section 301(a) of the FD&C Act, 21 U.S.C. 331(a). Cosmetics Manufactured for Distribution in the United States In addition, some of the products you manufacture may be regulated as cosmetics, as defined in section 201(i) of the FD&C Act [21 U.S.C. 321(i)]. Any cosmetics you manufacture must comply with applicable statutory and regulatory requirements, including the FD&C Act. We note that under section 301(a) of the FD&C Act [21 U.S.C. 331(a)], it is a prohibited act to introduce or deliver for introduction into interstate commerce a cosmetic that is adulterated or misbranded. We also note that the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) provides new requirements with which facilities that manufacture cosmetic products must comply. You may find the FD&C Act, MoCRA, and FDA’s regulations through links on FDA’s website at www.fda.gov. Drug Production Suspended We acknowledge your commitment to suspend production of OTC drug products “that do not meet the required testing and systemic rigor” at this facility. If you plan to resume any manufacturing operations regulated under the FD&C Act, notify this office before resuming your drug manufacturing operations. You are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance. In addition, based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of all corrective action and preventive action, before you pursue resolution of your firm’s compliance status with FDA. Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance. In your notification to the Agency, provide a summary of your remediations to demonstrate that you have appropriately completed all CAPA. View the regulator's official source
2026-07-13
US FDA
8 findingsQuality unit oversight · Deviation, CAPA, and investigation · Equipment and facility · Computer system validation · Laboratory and QC controls · Process validation The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. View the regulator's official source
About this page
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
What is included. As of 2026-10-20, only documents that have a detail page (at least 3 findings) are listed. The company may have more documents; the full set is available in Company lookup below.
Companies are grouped by a normalised key, not the displayed name — “… Limited” and “… Ltd.” count as the same company. Translation and classification are automated and may differ in nuance from the source; the basis for judgement is always the regulator's published document.
