CDL Services, Inc. DBA Technichem MARCS-CMS 713877 — November 24, 2025

WARNING LETTER

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• Delivery Method: VIA UPS
• Reference #: 320-26-21
• Product: Drugs ; Over-the-Counter Drugs

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• Recipient: Mr. Luis F Salazar; President/CEO; CDL Services, Inc. DBA Technichem ; 3800 E Miraloma Avenue; Anaheim, CA 92806; United States

• Issuing Office: Center for Drug Evaluation and Research (CDER); United States

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Warning Letter 320-26-21

November 24, 2025

Dear Mr. Salazar:

The U.S. Food and Drug Administration (FDA) conducted an inspection at CDL Services, Inc. DBA Technichem, FEI 3012112742, located at 3080 E La Jolla Street, Anaheim, CA, from April 7 to 28, 2025.

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).

We reviewed your May 15, 2025, response to our Form FDA 483 in detail.

During our inspection, our investigators observed specific violations including, but not limited to, the following.

1. Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)).

Your firm manufactures over-the-counter (OTC) drug products including hand sanitizers and (b)(4) hand soap. Your firm failed to adequately test batches of your drug products for the identity and strength of your active ingredients (e.g., ethanol and chloroxylenol) before release and distribution. For example, you stated that finished product testing data provided during the inspection was generated using simulated results and that no testing had been performed on finished drug products in over a year. As a result, your firm released drug product to the market without appropriate testing, review, and approval to ensure satisfactory conformance to final specifications for strength and identity.

In your response, you commit to testing products prior to distribution and testing the “most recently distributed” batches. Your response is inadequate in that it does not provide sufficient documentation for finished product testing (e.g., proposed test methodology or specifications). Moreover, your response fails to provide a timeline for when this testing will be completed or to perform any risk assessment.

Testing is essential to ensure that the drug products you manufacture conform to all pre-determined quality attributes appropriate for their intended use. Because you lacked adequate testing of each batch of your drug products, you do not know whether they conform to all appropriate finished product specifications and are suitable for release to consumers.

In response to this letter, provide a list of chemical and microbial specifications, including test methods, used to analyze each lot of your drug products before a lot disposition decision.

• An action plan and timelines for conducting full chemical and microbiological testing of retain samples to determine the quality of all batches of drug products that are within expiry as of the date of this letter.
• A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product 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 drug products. For example, you did not perform identity testing on each shipment of each lot of incoming components, such as glycerin, ethanol and chloroxylenol. Additionally, you relied on your suppliers’ certificates of analysis without verifying your supplier’s test results at appropriate intervals. Furthermore, you have not ensured that water used as a component is suitable for its intended use (e.g., (b)(4) Water, United States Pharmacopeia (USP) monograph).

Products Containing Ethanol

You failed to adequately test your incoming component ethyl alcohol (ethanol) at risk of methanol contamination for identity before using it as an active pharmaceutical ingredient (API) in manufacturing your OTC topical drug products. The use of ethanol contaminated with methanol has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol to help you meet the CGMP requirements when manufacturing drugs containing ethanol at https://www.fda.gov/media/173005/download.

Products Containing Ingredients at Risk for Diethylene Glycol or Ethylene Glycol (DEG or EG) Contamination

You also failed to adequately test your incoming components at high risk of diethylene glycol (DEG) or ethylene glycol (EG) contamination for identity before using them to manufacture your drug products. This includes, but is not limited to, testing of glycerin and propylene glycol to determine its appropriate identity, prior to use in manufacturing your OTC topical drug products.

Identity testing for glycerin, propylene glycol and certain other high-risk drug components includes a limit test in the USP to ensure the component meets the relevant safety limits for DEG or EG 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 assure the acceptability of these components for use in the manufacture of your drug products.

The use of ingredients contaminated with DEG or EG has resulted in various lethal poisoning incidents in humans worldwide. See FDA’s guidance document Testing of Glycerin, Propylene Glycol, Maltitol Solution, Hydrogenated Starch Hydrolysate, Sorbitol Solution, and Other High Risk Drug Components for Diethylene Glycol and Ethylene Glycol to help you meet the CGMP requirements when manufacturing drugs containing ingredients at high-risk for DEG or EG contamination at https://www.fda.gov/media/167974/download.

Water Used as a Component in Drug Products

Moreover, your firm uses water as a component in the manufacture of your drug products. Your firm has not demonstrated that the water is suitable for its intended use in pharmaceutical manufacturing. At a minimum, such water must meet the (b)(4) Water, USP monograph and appropriate microbial limits.

In your response, you commit to performing identity testing of components, testing for methanol and DEG/EG in high-risk components, and testing of your water used as a component. Your response is inadequate in that you did not provide a detailed plan for how your components will be assessed against compendial requirements. Furthermore, it did not include sufficient information regarding test methods or a timeline for implementing the proposed corrective actions.

Without adequate testing, you do not have scientific evidence that the components conform to appropriate specifications prior to use in the manufacture of your drug products. As a manufacturer, you have a responsibility to sample, test, and examine drug components before use in production to assure adequate quality.

In response to this letter, provide:

• A summary of results obtained from testing all components to evaluate the reliability of the certificate of analysis (COA) from each component manufacturer. Include your standard operating procedure (SOP) that describes this COA validation program.
• A commitment to provide DEG and EG test results, no later than 30 calendar days from the date of this letter, from testing retains for all lots of high-risk drug components used in the manufacture of drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches for the presence of DEG and EG.
• A full risk assessment for drug products that are within expiry which contain any ingredient at risk for DEG or EG contamination (including, but not limited to, glycerin). Take prompt and appropriate actions to determine the safety of all lots of the component(s) and any related drug product that could contain DEG or EG, 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.
• 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 revalidation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot. In the case of glycerin, propylene glycol, and certain additional high-risk components we note that this includes the performance of parts A, B, and C of the USP monograph.
• The chemical and microbiological quality control specifications you use to test each incoming lot of components, including high-risk drug components, to determine acceptability for use in manufacturing.
• 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.
• A commitment to provide methanol test results, no later than 30 calendar days from the date of this letter, from testing retains for all lots of components within expiry of manufactured drug products. Alternatively, if a retain of a component lot is unavailable, perform retain sample testing of all implicated finished drug product batches for the presence of methanol.
• A procedure governing your program for ongoing control, maintenance, and monitoring that ensures your water system consistently produces water that meets (b)(4) Water, USP monograph specifications and appropriate microbial limits.

3. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).

Your quality unit (QU) lacked adequate control over your OTC drug product manufacturing operations and failed to ensure that you had adequate procedures. For example, your quality unit (QU) failed to ensure the following:

• Establishment of adequate procedures describing the roles and responsibilities of the QU, including review of complaints, supplier qualification, change control and periodic product quality review (21 CFR 211.22(a) and 211.22(d)).
• Establishment of appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records or other records (21 CFR 211.68(b)).
• Establishment of adequate production procedures and process control to assure your drug products have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)).
• Drug products bear expiration dates that are supported by appropriate stability testing (21 CFR 211.137(a)).
• Establishment of adequate batch production and control records that contain the accomplishment of each significant step in the manufacture, processing, packing, or holding of the batch, for each batch of drug product (21 CFR 211.188(b)).

In your response, you commit to establishing a dedicated QU with associated procedures. Your response is inadequate in that it lacks detail on systemic remediations for your QU and improvements to your quality system. Your response also fails to provide details on how your QU will have the responsibility and authority to perform its functions.

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

In response to this letter, provide:

• A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:
  o A determination of whether procedures used by your firm are robust and appropriate
  o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices
  o A complete and final review of each batch and its related information before the QU disposition decision
  o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products
• A complete assessment of documentation systems used throughout your manufacturing and laboratory operations to determine where documentation practices are insufficient. Include a detailed corrective action and preventive action (CAPA) plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation.
• 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 monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control. Also, include your program for qualification of your equipment and facility.
• A comprehensive, independent assessment and CAPA plan to ensure the adequacy of your stability program. Your remediated program should include, but not be limited to:
  o Stability indicating methods
  o Stability studies for each drug product in its marketed container-closure system before distribution is permitted
  o An ongoing program in which representative batches of each product are added each year to the program to determine if the shelf-life claim remains valid
  o Detailed definition of the specific attributes to be tested at each station (timepoint)

Access to Information During Inspection

During the inspection, the gas chromatograph and the associated CGMP computer system were not available to the inspection team. This limited FDA’s access to records for inspection to evaluate the CGMP compliance status of your facility.

When an owner, operator, or agent delays, denies, limits, or refuses an inspection, the drugs may be deemed adulterated under section 501(j) of the FD&C Act. See FDA’s guidance document Circumstances that Constitute Delaying, Denying, Limiting, or Refusing a Drug or Device Inspection at https://www.fda.gov/media/86328/download.

CGMP Consultant Recommended

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 evaluate your operations and 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 your CAPAs before you pursue resolution of your firm’s compliance status with FDA. See FDA’s guidance document Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations for guidance on implementing modern quality systems and risk management approaches to meet the requirements of the Agency's CGMP regulations at https://www.fda.gov/media/71023/download.

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.

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.

Conclusion

The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.

Correct any violations promptly. Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction. Unresolved violations also 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 man-ufacturer 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.

This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.

Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3012112742 and ATTN: Andrew Haack, Compliance Officer.

Sincerely,
/S/

Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research