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  1. Warning Letters

WARNING LETTER

ABBE Laboratories, Inc. MARCS-CMS 708309 —

Delivery Method:
VIA EMAIL WITH READ RECEIPT
Reference #:
320-25-98
Product:
Drugs
Over-the-Counter Drugs
Recipient:
Recipient Name
Mr. Paul A. Iannuzzo
Recipient Title
Managing Director
ABBE Laboratories, Inc.

1095 Route 110, Suite E, F
Farmingdale, NY 11735-4815
United States

Issuing Office:
Center for Drug Evaluation and Research (CDER)

United States

Warning Letter 320-25-98

August 6, 2025

Dear Mr. Iannuzzo:

The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, ABBE Laboratories, Inc., FEI 3004433842, located at 1095 Route 110, Suite E, F, Farmingdale, New York, from February 24 to 27, 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 March 11, 2025, response to our Form FDA 483 in detail. Your response is inadequate because you failed to provide supportive documentation for evaluation or adequate evidence of corrective actions taken to bring your operations into compliance with CGMP. In your response, you commit to the creation of standard operating procedures (SOPs) and work instructions to comply with CGMP regulations; however, no details were provided on the content of these documents.

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

1. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. 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 manufactures and repackages over-the-counter (OTC) drug products, including topical liquids and ointments, without adequate assurance of the quality of components used in their manufacture. For example, you failed to adequately test your incoming components, including identity testing for each shipment of each component lot used in the manufacture of your OTC drug products. Instead, you relied on your suppliers’ certificate of analysis (COA) without establishing the reliability of your component suppliers’ test analyses at appropriate intervals.

Products Containing High-Risk Drug Components

You also failed to adequately test for identity each shipment of every lot of propylene glycol and glycerin, components at higher risk of diethylene glycol (DEG) or ethylene glycol (EG) contamination, received at your facility. Identity testing for propylene glycol, glycerin, and certain other high-risk drug components includes a limit test in the United States Pharmacopeia (USP) to ensure the component meets the relevant safety limits for levels of DEG or EG. 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.

In response to this letter provide:

  • 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 corrective actions and preventive actions (CAPAs) 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 United States Pharmacopeia (USP) monograph.
  • The chemical quality control specifications you use to test each incoming lot of 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.

2. Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)).

You have not demonstrated that your cleaning practices are adequate to remove contaminants from the shared equipment used to manufacture your OTC drug products.

Inadequate Cleaning Validation

Your 2009 cleaning validation study for the Kettle (b)(4) equipment is inadequate to ensure your cleaning procedures are effective for the multiple OTC drug products your firm manufactures. For example, the cleaning validation study did not include a determination of the worst-case drug product for this shared equipment and lacked the identity of the drug product cleaned during the study. You also failed to perform a new cleaning validation study when you began manufacturing a new drug product, End Zit Acne Drying Lotion, which you determined to be the most difficult to clean product due to the titanium dioxide active ingredient, on shared equipment.

In addition, the cleaning validation study for your kettle lacked analysis for API residues.

Inadequate Cleaning Documentation

Although your procedures define the cleaning steps, you lacked documented evidence that you performed each step of the cleaning process as required. Your procedure, ABBE-010, requires that you document all cleaning and sanitization information into the cleaning and sanitizing logbooks; however, you stopped documenting cleaning activities in your logbooks and status of the equipment around 2020.

In response to this letter provide:

  • A CAPA plan, based on the retrospective assessment of your cleaning and disinfection program, that includes appropriate remediations to your cleaning processes and practices, and timelines for completion. Provide a detailed summary of vulnerabilities in your process for lifecycle management of equipment and disinfection cleaning. Describe improvements to your cleaning and disinfection program, including enhancements to cleaning effectiveness; improved ongoing verification of proper cleaning and disinfection execution for all products and equipment; and all other needed remediations.
  • 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 of lower solubility in their cleaning solvents
    o Drugs with characteristics that make them difficult to clean
    o Swabbing locations for areas that are most difficult to clean
    o Maximum dirty and clean hold times before cleaning

In addition, describe the steps that must 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.

3. Your firm failed to establish 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)).

You failed to demonstrate you adequately validated the manufacturing processes for your OTC drug products. You stated that you validated the process for (b)(4) Sunscreen, (b)(4) SPF 30, (b)(4) SPF 30, and End Zit Acne Drying Lotion; however, you were unable to provide a validation protocol and corresponding report with established parameters (e.g., mixing speeds, temperature, hold times prior to filling) to demonstrate process control for each product you manufacture.

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. Without adequate process validation, incorporating all manufacturing inputs and parameters that can affect product quality, your firm lacks basic assurance that you can reproducibly deliver products that meet specifications. See FDA's guidance for industry, 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.

This is a repeat finding from your 2018 inspection when you committed to initiate process validation by September 2018 and forward final reports to FDA upon completion. The current inspection found that you failed to fulfill this commitment.

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 (PPQ), and ongoing monitoring of both intra-batch and inter-batch variation to ensure a continuing state of control.
  • A timeline for performing appropriate PPQ for each of your marketed drug products.
  • Process performance protocol(s), and written procedures for qualification of equipment and facilities.
  • A detailed program for designing, validating, maintaining, controlling and monitoring each of your manufacturing processes that includes vigilant monitoring of intra-batch and inter-batch variation to ensure an ongoing state of control. Also, include your program for qualification of your equipment and facility.

4. Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow written procedures applicable to the quality control unit (21 CFR 211.22(d)).

You lacked adequate oversight for the manufacture and repackaging of your OTC drug products. For example, you failed to ensure:

  • Establishment of suitable quality oversight procedures (e.g., investigations, returns/complaints, CAPA, and label reconciliation).
  • Implementation of adequate documentation practices. For example, we collected documents, including batch records and an out-of-specification investigation record, that were incomplete (e.g., documents had blank spaces, missing signatures), although the OTC drug products were released by your quality unit (QU).
  • Performance of an appropriate periodic (at least annual) review of drug product production. For example, you failed to perform annual product reviews of your OTC drug products since at least 2018.
  • Adherence to procedures for batch release. For example, you failed to complete the Finished Product Final Release Checklist for at least (b)(4) batches of OTC drug products already distributed to the market.

Complete and accurate batch production and control records are necessary to ensure that manufacturing processes are consistently followed and reproducible. Additionally, incomplete manufacturing records deprive you of the ability to reliably conduct batch record review, adequately investigate deviations and batch failures, and to ensure a continued state of validation processes.

An adequate QU overseeing all manufacturing operations is necessary to consistently ensure drug quality. Your firm’s quality systems are inadequate. See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help in 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 CAPA plan that comprehensively remediates your firm’s documentation practices to ensure you retain attributable, legible, complete, original, accurate, contemporaneous records throughout your operation.

Repeat Violations at Facility

In a previous inspection, dated August 7 to 10, 2018, FDA cited similar CGMP violations for the lack of process validation and lack of annual product review. You proposed specific remediation for these violations in your response. Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.

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 may 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 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.

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 3004433842 and ATTN: Vilmary Negrón Rodríguez.

Sincerely,
/S/

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

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