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  1. Warning Letters

WARNING LETTER

Bentley Laboratories LLC MARCS-CMS 732028 —

Delivery Method:
VIA UNITED PARCEL SERVICE
Reference #:
320-26-126
Product:
Drugs
Over-the-Counter Drugs
Recipient:
Recipient Name
Mr. James Burke
Recipient Title
President
Bentley Laboratories LLC

111 Fieldcrest Avenue
Edison, NJ 08837-3622
United States

james.burke@bentleylabs.com
Issuing Office:
Center for Drug Evaluation and Research (CDER)

United States

Secondary Issuing Offices

United States

September 17, 2026

WARNING LETTER
Reference number: 320-26-126

To Mr. James Burke:

This warning letter advises you of significant violations observed during a U.S. Food and Drug Administration (FDA) inspection of your products, processes, facilities, and records. Promptly address the violations described herein without delay, including ensuring that appropriate resources are allocated to fully address the violations and prevent their recurrence. This is not intended to be an all-inclusive list of the violations that exist at your facility. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations. Failure to adequately address violations may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.

FDA Inspection and Review

Violations were observed and documented during an inspection of your drug manufacturing facility, Bentley Laboratories LLC, FDA Establishment Identifier (FEI) 2244819, at 111 Fieldcrest Avenue, Edison, from March 16 to 27, 2026. This inspection was conducted under FDA’s statutory authority and public health responsibilities to protect the public from unsafe, ineffective, and poor quality drugs.

This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).

In addition, violations were identified and documented during a review of product labeling collected during the onsite inspection. Based on our review, “Geologie Acne Control Body Wash” and “Perricone MD Acne Relief Maximum Strength Spot Gel” are unapproved new drugs under section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 355(a). In addition, these products are misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). As explained further below, introducing or delivering these products for introduction into interstate commerce is prohibited under sections 301(a) and 301(d) of the FD&C Act, 21 U.S.C. 331(a) and 331(d).

We reviewed your April 21, 2026, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.

Violations of the Federal Food, Drug, and Cosmetic Act

The following are violations identified during our inspection and review. As a reminder, this is not an all-inclusive list of violations at your facility.

CGMP Violations

1. Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).

(b)(4) drug products such as (b)(4). Your firm failed to adequately investigate several out-of-specification (OOS) laboratory results. For example:

  • You failed to adequately investigate and scientifically identify the root cause for OOS assay results for lot (b)(4) at the (b)(4) at the 24-month stability timepoint of (b)(4). You also did not adequately evaluate the impact to products on the market.
  • You failed to adequately investigate an OOS result for (b)(4), lot (b)(4), for pH at the 36-month stability timepoint. Moreover, as a corrective action and preventive action (CAPA), your firm expanded the pH specification range without scientific justification.

You did not thoroughly investigate these failures of a component or drug product to meet any of its specifications. Your investigations were inadequate because you failed to identify the root cause, implement appropriate CAPA, and expand the investigation to evaluate the impact on other batches or products.

In your response, you state the root cause of inadequate investigations was due to deficiencies in your investigation procedures. Your response is inadequate. You fail to include changes to your investigation procedures to require root cause assessment for OOS results. Inadequate investigations can lead to unidentified root causes, ineffective CAPA, and recurring problems that compromise the ability to manufacture safe and effective drug products.

For more information about handling out-of-specification and failing test results, and documentation of your investigations, see FDA’s guidance document Investigating Out-of-Specification (OOS) Test Results for Pharmaceutical Production at https://www.fda.gov/media/158416/download.

In response to this letter, provide:

  • A comprehensive, independent assessment of your overall system for investigating (b)(4), discrepancies, complaints, OOS results, and failures. Provide a detailed action plan to remediate this system. Your action plan should include, but not be limited to, significant improvements in investigation competencies, scope determination, root cause evaluation, CAPA effectiveness, quality unit (QU) oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.
  • An independent assessment and remediation plan for your CAPA program. Provide a report that evaluates whether the program includes effective root cause analysis, ensures CAPA effectiveness, analyzes investigation trends, improves the CAPA program whenever needed, ensures final QU decision authority, and is fully supported by executive management.
  • A comprehensive, independent assessment of your change management system. This assessment should include, but not be limited to, your procedures to ensure changes are justified, reviewed, and approved by your QU. Your change management program should also include provisions for determining change effectiveness.
  • Your action plan to address any product quality or patient safety risks for your drug products in U.S. distribution, including customer notifications and recalls.

2. Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).

Your firm failed to ensure that components were suitable for use in manufacturing your OTC (b)(4) drug products. For example, you did not perform adequate identity testing on each shipment of each lot of incoming components (e.g., (b)(4)). Additionally, you relied on your suppliers’ certificates of analysis (COA) without establishing the reliability of each of your component suppliers’ test analyses at appropriate intervals.

Products Containing (b)(4)

You manufacture multiple drugs that contain (b)(4) (e.g., (b)(4)). You failed to adequately test your incoming (b)(4) for (b)(4) contamination. The use of (b)(4) contaminated with (b)(4) has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document (b)(4).

In your response, you state that you initiated a change control request “to modify the system to ensure (b)(4) impurity testing is included” and tested raw materials for (b)(4) impurities. Your response is inadequate because you do not provide sufficient detail about your updated raw material specifications and how you will ensure performance of appropriate incoming testing for each component. Also, you failed to indicate whether you lack retain samples of any batches and are therefore unable to test them for impurities. Additionally, you failed to demonstrate that the (b)(4) you used as a component to manufacture your drug products met USP monograph specifications including those for impurities (e.g., (b)(4)).

Products Containing (b)(4)

You also failed to adequately test your incoming components at high risk of (b)(4) contamination for identity before using them to manufacture your drug products. This includes, but is not limited to, testing of (b)(4) to determine its appropriate identity before using it in manufacturing your OTC (b)(4) drug products.

Identity testing for glycerin and certain other high-risk drug components includes a limit test in the USP to ensure that the component meets the relevant safety limits for (b)(4) or (b)(4) levels. Because you did not perform identity testing on each shipment of each lot using the USP identification test that detects these hazardous impurities, you failed to ensure the acceptability of these components for use in the manufacture of your drug products.

The use of ingredients contaminated with (b)(4) has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document (b)(4) to help you meet the CGMP requirements when manufacturing drugs containing ingredients at high-risk for (b)(4) contamination at (b)(4).

In your response, you state that you initiated a change control request “to modify the test procedure to ensure the inclusion of (b)(4)” and tested raw materials for (b)(4). Your response is inadequate because you do not provide sufficient documentation of your updated raw material specifications and how you will ensure performance of appropriate testing on incoming components. Also, you failed to indicate whether you lack retain samples of any batches and are therefore unable to test them for hazardous impurities.

Without adequate testing, you do not have scientific evidence that the components conform to the appropriate specifications before their use in the manufacture of your drug products. You are responsible for sampling, testing, and examining drug components before their use in production to ensure that acceptable quality parameters are met.

In response to this letter, provide:

  • A comprehensive, independent review of your material system to determine whether all suppliers of components, containers, and closures are each qualified and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.
  • The chemical and microbiological quality control specifications you use to test and release each incoming lot of component for use in manufacturing.
  • A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your supplier’s COA instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your supplier’s results through initial validation as well as periodic re-validation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot. In the case of (b)(4), and certain additional high-risk components, we note that this includes the performance of parts (b)(4) of the USP monograph.
  • Based on a thorough review, provide a summary of your systems CAPA to remediate the vendor qualification program and prevent use of unsuitable components, containers and closures.
  • A commitment to perform reconciliation of retains tested versus all lots used in production. If retain samples are unavailable, a commitment to test finished drug product batches for the presence of (b)(4). Also include your analytical methods.
  • A summary of your program for qualifying and overseeing contract facilities that test the components and drug products you manufacture.
  • A full risk assessment for drug products that are within expiry which contain any ingredient at risk for (b)(4) contamination (including, but not limited to, (b)(4)). Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain (b)(4), including customer notifications and product recalls for any contaminated lots.

Identify additional appropriate CAPA that secure supply chains in the future, including, but not limited to, ensuring that all incoming raw material lots are from fully qualified manufacturers and free from unsafe impurities. Detail these actions in your response to this letter.

3. Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).

Your firm failed to adequately validate your manufacturing processes for OTC drug products. You did not revalidate your manufacturing processes after making major process changes, nor did you fully execute validation protocols through the completion of all batches. For example, you changed the manufacturing process for (b)(4) to rephase the formulation without revalidation and outside of your change management system. Also, for (b)(4), your process validation execution deviated from your Validation Master Plan (VMP) which requires validating your manufacturing processes with three batches. Furthermore, you did not retain stability samples from any of the three batches.

Your firm also failed to adequately validate your cleaning processes for non-dedicated equipment used to manufacture (b)(4). For the two validation batches where cleaning validation swab samples were collected, OOS results for residual of active pharmaceutical ingredients were not adequately investigated.

In your response, you state a change control will be conducted for the (b)(4) and, if required, a process validation will be performed for the revised process. You also state you will complete the validation for the (b)(4) and will update your VMP as well as applicable standard operating procedures (SOPs).

Your response is inadequate because you do not commit to revalidating the (b)(4) process. Additionally, you do not evaluate the roles and responsibilities of your QU, including change management and document control, to ensure comprehensive oversight functions.

Also, it appears that you used a maximum allowable carryover limit of (b)(4) ppm in your cleaning validation calculations without adequate scientific justification. Without adequate process validation that incorporates all manufacturing inputs and parameters that can affect product quality, your firm lacks basic assurance that you can reproducibly deliver products that meet specifications.

Process validation evaluates the soundness of design and state of control of a process throughout its lifecycle. Each significant stage of a manufacturing process must be designed appropriately and assure the quality of raw material inputs, in-process materials, and finished drugs. Process qualification studies include intensive monitoring and testing throughout each significant process stage to characterize intra-batch variation and evaluate batches to determine whether an initial state of control has been established.

Successful process qualification studies are necessary before commercial distribution. Thereafter, ongoing vigilant oversight of process performance and product quality is necessary to ensure you maintain a stable manufacturing operation throughout the product lifecycle.

See FDA’s guidance document Process Validation: General Principles and Practices for general principles and approaches that FDA considers appropriate elements of process validation at https://www.fda.gov/media/71021/download.

In response to this letter, provide:

  • A detailed summary of your validation program for ensuring a state of control throughout the product lifecycle, along with associated procedures. Describe your program for process performance qualification, and ongoing vigilant monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control.
  • A timeline for performing appropriate process performance qualification for each of your marketed drug products.
  • A risk assessment for the distributed drug products produced using inadequately validated processes.
  • Appropriate improvements to your cleaning validation program, with special emphasis on incorporating conditions identified as worst case in your drug manufacturing operation. This should include, but not be limited to, identification and evaluation of all worst-case:
    o drugs with higher toxicities
    o drugs with higher drug potencies
    o drugs of lower solubility in their cleaning solvents
    o drugs with characteristics that make their manufacturing equipment difficult to clean
    o swabbing locations for areas that are most difficult to clean
    o maximum hold times before cleaning
  • A description of the steps that will be taken in your change management system before introduction of new manufacturing equipment or a new product.
  • A summary of updated SOPs that ensure an appropriate program is in place for verification and validation of cleaning procedures for products, processes, and equipment.
  • A comprehensive, independent retrospective assessment of your cleaning effectiveness to evaluate the scope of cross-contamination hazards. Include the identity of residues, other manufacturing equipment that may have been improperly cleaned, and an assessment whether cross-contaminated products may have been released for distribution. The assessment should identify any inadequacies of cleaning procedures and practices, and encompass each piece of manufacturing equipment used to manufacture more than one product.

Quality Systems

Your firm’s quality systems are inadequate. For help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211, see FDA’s guidance documents Quality Systems Approach to Pharmaceutical CGMP Regulations at https://www.fda.gov/media/71023/download.

Significant findings in this letter demonstrate that your firm does not operate an effective quality system in accord with CGMP. In addition to the lack of effective management oversight of your production and laboratory operations, we found your quality unit is not enabled to exercise proper authority and/or has insufficiently implemented its responsibilities. Executive management should immediately and comprehensively assess your company’s global manufacturing operations to ensure that your systems, processes, and products conform to FDA requirements.

Responsibilities as a Contractor

Drugs must be manufactured in conformance with CGMP. FDA is aware that many drug manufacturers use independent contractors such as production facilities, testing laboratories, packagers, and labelers. FDA regards contractors as extensions of the manufacturer.

You are responsible for the quality of drugs you produce as a contract facility regardless of agreements in place with product owners. You are required to ensure that drugs are made in accordance with section 501(a)(2)(B) of the FD&C Act for safety, identity, strength, quality, and purity. See FDA’s guidance document Contract Manufacturing Arrangements for Drugs: Quality Agreements at https://www.fda.gov/media/86193/download.

Unapproved New Drug Violations

Based on a review of the product labeling, “Geologie Acne Control Body Wash” and “Perricone MD Acne Relief Maximum Strength Spot Gel” are “drugs” under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or intended to affect the structure or any function of the body. Examples from your product labeling that provide evidence of the intended use (as defined in 21 CFR 201.128) of these products as a drug include, but may not be limited to, the following:

Geologie Acne Control Body Wash

“2% Salicylic Acid…1.5% Glycolic Acid…Clears Skin Fast…Prevents New Breakouts… Drug Facts…Uses…For the treatment of acne. Penetrates pores to eliminate most acne blemishes, whiteheads, & blackheads. Helps prevent new acne blemishes.” [from the product label]

Perricone MD Acne Relief Maximum Strength Spot Gel

“Acne Relief…Drug Facts…Uses…For the treatment of acne…KEY INGREDIENTS Lactic & Succinic Acids: Target Acne-Causing Bacteria…help minimize blemishes…Citrulline: Fight & Visibly Reduce Redness…Tea Tree Oil: Clarify & Soothe… helps soothe the skin & visibly reduce redness.” [from the product label]

Based on the above labeling evidence, “Geologie Acne Control Body Wash” and “Perricone MD Acne Relief Maximum Strength Spot Gel” are intended for use as acne drug products. As described below, these drug products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act, 21 U.S.C 355(a) and 331(d).

A drug product is a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. 321(p), if it is not generally recognized as safe and effective (GRASE) for use under the conditions prescribed, recommended, or suggested in its labeling. With certain exceptions not applicable here, a new drug may not be introduced or delivered for introduction into interstate commerce without an approved application from FDA in effect, as described in section 505(a) of the FD&C Act, 21 U.S.C. 355(a). No FDA-approved applications pursuant to section 505 of the FD&C Act, 21 U.S.C. 355, are in effect for these drug products identified above.

Under section 505G of the FD&C Act, certain nonprescription drugs marketed without an approved application —commonly referred to as "OTC monograph drugs"—may be legally marketed if they meet applicable requirements. With respect to nonprescription acne drug products, such as your “Geologie Acne Control Body Wash” and “Perricone MD Acne Relief Maximum Strength Spot Gel”, in order to be GRASE and not new drugs, the products must, among other things, conform to the conditions in the applicable OTC monograph(s), here M006 (Topical Acne Drug Products for Over-the-Counter Human Use).1 However, “Geologie Acne Control Body Wash” and “Perricone MD Acne Relief Maximum Strength Spot Gel” do not conform to the conditions specified in M006 for the reasons described below.

Your product "Geologie Acne Control Body Wash" includes the active ingredient Glycolic Acid, which is not a permitted active ingredient under M006.10. 21. 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.

Conclusion

As previously stated, you are responsible for investigating and determining the root causes of any violations and implementing corrective and preventative measures to ensure future and sustained compliance so that these violations and any others do not occur.

Unresolved violations may prevent other Federal agencies from awarding contracts. Failure to address violations may also cause FDA to withhold issuance of Export Certificates. FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP. We may re-inspect to verify that you have completed corrective actions to address any violations.

Send your written response to CDER-OC-OMQ-Communications@fda.hhs.gov within fifteen (15) business days of receipt of this letter. Identify your written response with FEI 2244819 and ATTN: Sena G. Dissmeyer in the letter or in the subject line of the email.

If you have information that you believe demonstrates that your products are not in violation of the FD&C Act and FDA regulations, include that information for our consideration.

FDA posts warning letters on www.FDA.gov.

Sincerely,
/S/

Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

/S/

Tina Smith, M.S.
Captain, U.S. Public Health Service
Director
Office of Unapproved Drugs & Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

_______________________________

1 M006, in the final administrative order, Over-the-Counter Monograph M006: Topical Acne Drug Products for Over-the-Counter Human Use, reflects the conditions in the relevant final order established and in effect under section 505G. See Order ID OTC000013, available at FDA’s website OTC Monographs@FDA, https://www.accessdata.fda.gov/scripts/cder/omuf/.

2 FDA is not aware of any adequate and well-controlled clinical trials in the published literature that support a determination that “Geologie Acne Control Body Wash” and “Perricone MD Acne Relief Maximum Strength Spot Gel” products are GRASE for use under the conditions prescribed, recommended, or suggested in their labeling, nor has FDA determined these drug products to be GRASE pursuant to an order issued under section 505G(b).

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