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  5. ABR Laboratory LLC - 696872 - 02/10/2025
  1. Warning Letters

WARNING LETTER

ABR Laboratory LLC MARCS-CMS 696872 —

Delivery Method:
Via Email
Reference #:
320-25-42
Product:
Drugs
Recipient:
Recipient Name
Mr. Jorge D. Abraldes
Recipient Title
CEO
ABR Laboratory LLC

450 N Park Rd, Suite 303
Hollywood, FL 33021-6917
United States

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

United States

Warning Letter 320-25-42

February 10, 2025

Dear Mr. Abraldes:

The U.S. Food and Drug Administration (FDA) inspected your contract testing laboratory, ABR Laboratory LLC., FEI 3020570829, located at 450 North Park Road, Suite 303, Hollywood, FL 33021-6917, from September 9 to 13, 2024.

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, the drug products you tested 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 September 29, 2024 response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.

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

1. Your firm failed to establish and document the accuracy, sensitivity, specificity, and reproducibility of its test methods (21 CFR 211.165(e)).

Your firm is a contract testing lab that analyzes drugs for your customers. You did not use a suitable method to test your client’s over-the-counter (OTC) drug products. For example, your method was not verified to be equivalent or better than the United States Pharmacopeia (USP) method used to test multiple OTC) drug products for potential microbial contamination. Your method for Plate Count (b)(4) growth media is different in composition to the Soybean-Casein Digest Agar required for plate count methods by USP<61> Microbiological Examination of Nonsterile Products: Microbial Enumeration Tests. You have not demonstrated your method is equivalent or better than the USP<61> compendial method. Additionally, you failed to perform method suitability for the microbial testing of (b)(4) and (b)(4) OTC drug products. The (b)(4) drug product is intended for (b)(4) symptoms in children.

Method suitability testing ensures the method can reliably determine the presence of microbial growth in the drug product. Without evaluating the validity of methods, you lack assurance that the data provided to customers was an accurate reflection of pharmaceutical drug product quality and safety.

In your response you state you “have initiated a comprehensive validation of Test Method STP-002 Microbiological Testing of Raw Materials and Products” and “will conduct a suitability test for each product category.”

Your response is inadequate. You do not provide sufficient information to demonstrate that your methods are equivalent or better than the applicable USP compendial methods and suitable for their intended use. In addition, you state you will develop methods for each drug category; however, you do not provide data supporting your method for each product category is suitable for each individual drug product.

Responsibilities of Contract Testing Lab

FDA considers contractors as extensions of the manufacturer’s own facility. Your failure to comply with CGMP may affect the quality, safety, and efficacy of the drugs you test for your clients. It is essential that you understand your responsibility to operate in full compliance with CGMP, and that you inform all your customers of any out-of-specification (OOS) results or significant problems encountered during the testing of these drugs.

In response to this letter, provide:

  • A comprehensive independent assessment of your laboratory practices, procedures, methods, equipment, documentation, and analyst competencies. Based on this review, provide a detailed plan to remediate and evaluate the effectiveness of your laboratory system.
  • A retrospective review to determine the scope and the impact of the violation. The review should include a procedure to re-test drug product potentially affected by the violation and a procedure that details steps you will take in the case previously negative results are shown to be positive for microbial contamination, including notifying your customers.
  • Updated procedures documenting how the suitability of all test methods will be determined, when method verification and validation occur, and corresponding training records.

2. 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).

You failed to investigate out-of-range deviations in temperature and humidity readings in your laboratory equipment. For example, your 2 - 8°C refrigerator was out of range for more than 24 hours reaching temperatures of up to 17.4°C. This refrigerator houses the reference microorganisms used in your growth promotion tests. This deviation was not identified or investigated. Storing of reference microorganisms outside of their acceptable range compromises their ability to grow, thereby undermining their value as reference organisms and the accuracy of the results.

In your response, you state you will update your relevant procedures. You also commit to implementing a real-time monitoring system to alert staff of any temperature deviations.

Your response is inadequate. You fail to investigate the deviation to determine the scope and potential impact to the accuracy of your test results and you fail to identify a root cause to correct and prevent recurrence. You also do not commit to evaluating other laboratory and manufacturing equipment and their related procedures to ensure deviations are identified and investigated.

In response to this letter, provide a comprehensive, independent assessment of your overall system for investigating deviations, 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, corrective action and preventive action effectiveness, quality unit oversight, and written procedures. Address how your firm will ensure all phases of investigations are appropriately conducted.

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 assist your firm in meeting CGMP requirements.

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.

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 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 electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 3020570829 and ATTN: Carlos Gonzalez.

Sincerely,
/S/

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

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