Findings citing 21 CFR 211.142

Your firm failed to store drug products under appropriate conditions of temperature, humidity, and light so that the identity, strength, quality, and purity are not affected (21 CFR 211.142(b)). Your firm failed to establish and follow adequate temperature monitoring and warehousing procedures for finished drug products. For example, you released (b)(4) , batch (b)(4) , on (b)(4) , and stored it in Building (b)(4) , until you shipped it on (b)(4) . The product label specifies storage at (b)(4) °C– (b)(4) °C, however, you recorded high temperatures of (b)(4) °C– (b)(4) °C in Building (b)(4) during this storage period. The temperatures in Building (b)(4) exceeded both the labeled storage conditions and your firm's internal temperature monitoring protocol. A review of Building (b)(4) temperature data from April 2025 through March 2026 identified approximately (b)(4) weeks where temperatures exceeded (b)(4) °C. Exposure to elevated temperatures in (b)(4) -containing products poses a risk of (b)(4) contamination. Furthermore, your firm did not include storage condition requirements on your certificates of analysis (COAs). In your response, you commit to updating the procedure, revising temperature mapping protocols, conducting a retrospective evaluation of temperature monitoring data across all warehouse areas, and completing relevant personnel training. Your response is inadequate. You did not implement immediate corrective actions and did not conduct a thorough retrospective review of product impact for temperature excursions, including for the formation of impurities and degradants when products are exposed to heat. In response to this letter, provide: Your procedure for environmental controls and alarm limits for storage areas. A list of the different types of drug products and related materials you store in your warehouse (for example, finished drug products, unlabeled drug products, expired drug products, raw materials, and components) and a current inventory, including manufacturer-assigned expiration dates and status (for example, released, quarantined, rejected). A risk assessment for batch (b)(4) (vendor lot # (b)(4) ) addressing the impact of temperature excursions on product quality, including (b)(4) formation risk. A comprehensive retrospective review of temperature monitoring data across all storage and warehouse areas to identify any instances in which OTC drug products were stored outside of their labeled storage conditions. This review should encompass all products and all time periods for which temperature data is available and should result in a documented assessment of any affected lots, including an evaluation of potential impact on product quality, safety, and efficacy. A comprehensive review of all OTC finished drug product storage conditions across all buildings, comparing labeled storage requirements against recorded temperature data, with documentation of any corrective actions taken. Updated written procedures ensuring storage conditions are included on COAs and shipping labels. 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. Quality Unit Authority Your inspectional history indicates that your quality unit is not able to fully exercise its authority and/or responsibilities. Your firm must provide the quality unit with the appropriate authority and sufficient resources to carry out its responsibilities and consistently ensure drug quality. 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.

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 firm failed to establish an adequate quality unit (QU) with the responsibilities and authority to oversee the manufacturing of drug products. For example, your QU failed to ensure: Establishment of adequate batch production and control…

Your firm failed to store drug products under appropriate conditions of temperature, humidity, and light so that the identity, strength, quality, and purity are not affected (21 CFR 211.142(b)). You failed to have adequate storage and warehousing of drug products. For example, although a supplier’s certificate of analysis (COA) for a bulk drug stated that the drug is sensitive to heat, sunlight, and moisture, you failed to monitor storage conditions for the drug, including for temperature and humidity. You also acknowledged that there were inadequate storage conditions for drug products, and for your containers and closures. The holding of drug products must be performed under appropriate conditions so that the identity, strength, quality, and purity are not affected.

Your firm failed to follow written procedures regarding storage and warehousing of drug products (21 CFR 211.142).