GC America, Inc. MARCS-CMS 727602 — May 14, 2026

WARNING LETTER

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• Delivery Method: Via Email Return Receipt Requested
• Reference #: 320-26-76
• Product: Drugs ; Over-the-Counter Drugs

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• Recipient: Mr. Joseph T. Talanges; President & Chief Operating Officer ; GC America, Inc.; 3737 West 127th Street; Alsip, IL 60803; United States

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

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May 14, 2026

WARNING LETTER

 

Dear Mr. Talanges:

The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, GC America, Inc., FEI 1410097, at 3737 West 127th Street, Alsip, Illinois, from November 3 to 7, 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 November 21, 2025, 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 test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(1) and 211.84(d)(2)).

Your firm manufactures OTC drug products, including those for (b)(4). Your firm failed to ensure components were suitable for use in manufacturing your drug products.

(b)(4) Used as a Component in Drug Products

You did not adequately demonstrate your (b)(4), at a minimum, meets specifications in the United States Pharmacopeia (USP) (b)(4) monograph. For example, your (b)(4) system records show that you only performed (b)(4) testing. However, the USP monograph requires additional testing for chemical purity and microbial quality. We also noted you failed to establish a procedure describing (b)(4) sampling requirements and acceptance criteria. According to your management, you manufactured approximately (b)(4) finished drug batches with inadequately tested (b)(4) from 2023 through 2025.

Products Containing Ingredients at Risk for (b)(4) Contamination

You also state in your correspondence to the agency that you do not conduct identity testing on each shipment of each lot of your incoming components at high risk of (b)(4) contamination before using them to manufacture your drug products. This includes, but is not limited to, testing (b)(4) to determine its appropriate identity prior to use in manufacturing your drug products.

Identity testing for (b)(4) and certain other high-risk drug components includes a USP limit test to ensure the component meets the relevant safety limits for (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 assure 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).

In your response, you acknowledge you do not perform all testing of (b)(4) per USP, and you commit to sending a sample of your (b)(4) to a third-party testing laboratory. You also commit to conducting a risk assessment of your deficient (b)(4) testing on drug products released from 2023 to 2025 and to establishing a (b)(4) testing SOP.

Your response is inadequate. You do not provide a detailed procedure explaining how you will assess your (b)(4) against compendial requirements. You also lack a comprehensive review of your material system, including supplier evaluations, to ensure the quality of all materials is consistently acceptable.

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

In response to this letter, provide:

• A procedure for your (b)(4) system monitoring that specifies routine microbial testing of (b)(4) to ensure its acceptability for use in each batch of drug products produced by your firm.

• The current action/alert limits for total counts and objectionable organisms used for your (b)(4) system. Ensure that the total count limits for your (b)(4) are appropriately stringent in view of the intended use of each of the products produced by your firm.

• A procedure governing your program for ongoing control, maintenance, and monitoring that ensures the remediated system consistently produces (b)(4) that meets (b)(4) USP monograph specifications and appropriate microbial limits.

• A comprehensive, independent review of your material system, including but not limited to:
o evaluating all suppliers of materials (components, containers, and closures) to determine if they are reliable and appropriately qualified
o an assessment of all materials to determine whether they are consistently of acceptable quality
o a review to ensure assigned expiration or retest dates are appropriate (supported by data)
o adequacy of the supplier qualification program, and its selection, qualification, and disqualification provisions

• Based on a thorough review, provide a summary of your systems corrective actions and preventive actions (CAPA) to remediate the vendor qualification program and prevent use of unsuitable components, containers and closures.

• Your (b)(4) system qualification report.

• The chemical and microbiological quality control specifications you use to test and release each incoming lot of components for use in manufacturing, including high risk drug components.

• 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 certificates of analysis 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 (b)(4) of the USP monograph.

• A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture.

• A commitment to provide (b)(4) 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 (b)(4).

• 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.

2. Your firm failed to establish and follow a written testing program designed to assess the stability characteristics of drug products and to test an adequate number of batches of each drug product to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a) and 211.166(b)).

Your firm failed to establish a stability program with adequate data from long-term or accelerated storage conditions, demonstrating that drug products remain acceptable throughout the labeled expiry period. For example, the only stability data provided for (b)(4) consisted of a single batch tested for (b)(4) at (b)(4) degrees Celsius with no controlled humidity condition. Furthermore, you have no ongoing stability studies for any drugs currently manufactured.

Without an appropriate stability program, you lack adequate scientific evidence to demonstrate your drug products meet established specifications and retain their quality attributes through your labeled expiry.

See FDA’s guidance document Q1A(R2) Stability Testing of New Drug Substances and Products to help you meet the CGMP requirements for stability testing at https://www.fda.gov/media/71707/download.

In your response, you acknowledge you do not have an appropriate written testing program to assess the stability characteristics of your drugs. You also state you will test expired reserve samples and perform a risk assessment for distributing drugs without adequate stability data. You also commit to initiating ongoing stability testing and modifying your procedures to include updated stability instructions.

Your response is inadequate. You lack analytical data to show your drugs maintain their quality attributes throughout their shelf life. You also fail to provide updated procedures and training records indicating you have implemented an adequate stability program.

In response to this letter, provide:

• 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)
o all procedures that describe these and other elements of your remediated stability program

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

Your quality unit (QU) did not adequately oversee your drug manufacturing operations. For example, your QU failed to ensure adequate control of your analytical data. Our investigator documented an uncontrolled password for the (b)(4) meter affixed to a laptop by a sticker used for processing (b)(4) meter test results. In addition, the data from the (b)(4) meter is automatically deleted when the laptop is shutdown, so no records were available to show that your QU reviewed this data. Furthermore, you were unable to provide audit trails or an SOP describing oversight and retention requirements of electronic records. The lack of proper electronic record controls undermines the reliability and integrity of your laboratory data (21 CFR 211.68(b)).

Your QU also failed to perform annual product reviews of your drug products since our previous inspection in 2018. Furthermore, no written procedures for this requirement were available (21 CFR 211.180(e)).

In your response, you acknowledge you did not exercise appropriate controls to ensure authorized access to electronic records. Also, you commit to removing shared passwords, creating a data integrity policy, and implementing an annual product review procedure.

Your response is inadequate. You do not provide updated procedures and training records to demonstrate you have corrected your data control deficiencies. You also lack product quality assessments.

Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA’s guidance document Data Integrity and Compliance with Drug CGMP: Questions and Answers for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/media/119267/download.

We strongly recommend that you retain a qualified consultant to assist in your remediation. In response to this letter, provide:

• A comprehensive investigation into the extent of the inaccuracies in data records and reporting including results of the data review for drugs distributed in the United States. Include a detailed description of the scope and root causes of your data integrity lapses.

• A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity and analyses of the risks posed by ongoing operations.

• A management strategy for your firm that includes the details of your global corrective action and preventive action plan. The detailed corrective action plan should describe how you intend to ensure the reliability and completeness of all data generated by your firm including microbiological and analytical data, manufacturing records, and all data submitted to FDA.

• 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.

CGMP Consultant Recommended

Based upon the nature of the violations we identified at your firm, you should engage a qualified consultant 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 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 with 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 1410097 and ATTN: Matthew Jensen.

Sincerely,
Kennerly K. Chapman -S
Francis Godwin
Director
Digitally signed by Kennerly K. Chapman -S
Date: 2026.05.14 15:58:58 -04'00'
Office of Manufacturing Quality Office of Compliance
Center for Drug Evaluation and Research