SCA Pharmaceuticals, LLC MARCS-CMS 724202 — September 14, 2026

WARNING LETTER

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• Delivery Method: VIA ELECTRONIC MAIL READ/DELIVERY RECEIPT REQUESTED
• Product: Drugs

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• Recipient: Kenneth P. Bonnell; Chief Quality Officer; SCA Pharmaceuticals, LLC; 8821 Knoedl Court; Little Rock, AR 72205-4600; United States

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

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WARNING LETTER
WL # 724202

September 14, 2026

Dear Mr. Bonnell:

You registered your facility with the U.S. Food and Drug Administration (FDA) as an outsourcing facility under section 503B of the Federal Food, Drug, and Cosmetic Act (FDCA) [21 U.S.C. § 353b]¹ on December 13, 2013, and most recently on December 5, 2025. From October 20, 2025, to October 30, 2025, an FDA investigator inspected your facility, SCA Pharmaceuticals, LLC located at 8821 Knoedl Court, Little Rock, Arkansas 72205. During the inspection, the investigator noted serious deficiencies in your practices for producing drug products intended or expected to be sterile, which put patients at risk.

FDA issued a Form FDA 483 to your facility on October 30, 2025. We reviewed your November 21, 2025, and December 31, 2025, responses to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence. Based on this inspection, it appears you produced drugs that violate the FDCA.

A. Compounded Drug Products under the FDCA

Under section 503B(b) of the FDCA, a compounder can register as an outsourcing facility with FDA. Drug products compounded by or under the direct supervision of a licensed pharmacist in an outsourcing facility qualify for exemptions from the drug approval requirements in section 505 of the FDCA [21 U.S.C. § 355(a)], the requirement in section 502(f)(1) of the FDCA [21 U.S.C. § 352(f)(1)] that labeling bear adequate directions for use and the Drug Supply Chain Security Act requirements in section 582 of the FDCA [21 U.S.C. § 360eee-1] if the conditions in section 503B of the FDCA are met.

An outsourcing facility, which is defined in section 503B(d)(4) of the FDCA [21 U.S.C. § 353b(d)(4)], is a facility at one geographic location or address that — (i) is engaged in the compounding of sterile drugs; (ii) has elected to register as an outsourcing facility; and (iii) complies with all of the requirements of this section. Outsourcing facilities must comply with other applicable provisions of the FDCA, including section 501(a)(2)(B) [21 U.S.C. § 351(a)(2)(B)], regarding current good manufacturing practice (CGMP), and section 501(a)(2)(A) [21 U.S.C. § 351(a)(2)(A)], regarding insanitary conditions. Generally, CGMP requirements for the preparation of drug products are established in Title 21 of the Code of Federal Regulations (CFR) parts 210 and 211.

B. Violations of the FDCA

Adulterated Drug Products

The FDA investigator collected evidence indicating that drug products intended or expected to be sterile were prepared, packed, or held under insanitary conditions, whereby they may have become contaminated with filth or rendered injurious to health, causing your drug products to be adulterated under section 501(a)(2)(A) of the FDCA. For example, the investigator collected evidence indicating that:

1. Your facility lacked routine and rigorous certification of the ISO 5 areas, including airflow visualization studies performed under dynamic conditions.

2. Your firm did not perform adequate product evaluation and take appropriate corrective action after microbial contamination was recovered within the ISO 5 aseptic processing area.

3. Your component control is not adequately designed or maintained to prevent contamination of product contact surfaces due to the presence of foreign (unusual) material between the stopper ribs of syringes.

4. Your compounding technicians and aseptic assistants employ poor practices which introduce risk of microbial contamination into the ISO 5 classified critical areas during production of drugs intended to be sterile.

For example, during the production of Fentanyl Citrate 2 mcg/mL Bupivacaine HCl 0.125% lot #1125035913 and/or Methadone HCl 10 mg/mL lot #1125035922, your compounding technicians:

a. Moved quickly in a critical area or in an area immediately adjacent to a critical area such that unidirectional airflow is likely to be disrupted.

b. Leaned into the hood, allowing their head and upper body to enter the ISO 5 classified critical area, thereby disrupting unidirectional airflow.

c. Blocked first pass air by placing gloved hands directly over the following:

i. Hanging IV bag ports when making sterile connections.

ii. The IV bag ports when disinfecting prior to filling.

iii. The open filled syringes and the syringe cap trays during the process of screwing caps onto the syringes.

d. Conducted aseptic operations on or directly above the hood deck surface in vertical flow hoods, which prevents unidirectional first air with minimal turbulence from surrounding aseptic operations during sterile connections and filling of drug products intended or expected to be sterile into open sterile containers.

e. Regularly rested their arms on the work surface of the hood during aseptic production. This practice may introduce contamination into the ISO 5 work area.

Additionally, your aseptic assistants:

a. Moved quickly in an area immediately adjacent to a critical area such that unidirectional airflow is likely to be disrupted.

b. Used disinfectant in a manner insufficient to achieve adequate levels of disinfection of materials, such as the IV bag ports, during transfer into the ISO 5 classified critical areas by spraying very quickly or from a significant distance or failing to treat both sides of the IV bags. Prior to disinfection, aseptic assistants regularly touched the IV bag ports in the ISO 7 area with their gloved hands.

5. Your environmental monitoring program lacks adequate routine environmental monitoring that captures data representative of aseptic production conditions. For example, during the production of Fentanyl Citrate 2 mcg/mL Bupivacaine HCl 0.125% lot #1125035913:

a. The active air sampler is placed to the far right of the hood instead of adjacent to the areas where aseptic operations occur, including the left and center portions of the ISO 5 classified hood.

b. Compounding technicians do not always carefully roll their individual fingers across the media touch plate during personnel monitoring. The compounding technician quickly touched each fingertip to the media plates instead of methodically rolling their fingertips.

6. Your firm failed to perform adequate airflow visualization studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area. Your airflow visualization studies are deficient because:

a. The studies do not clearly demonstrate that the airflow pattern sweeps over and away from the critical areas near and on the ISO 5 classified LAF hood work surface where aseptic operations occur. Instead, the smoke appears to arc out of the hood significantly higher than the critical area and then travel up toward the ceiling in the surrounding ISO 7 classified area.

b. In your most recent airflow visualization study VAL-25-044-FR, you indicated that (b)(4) people are allowed in ISO 7 (b)(4) Room (b)(4) during aseptic operations; however, the smoke study videos provided during the FDA inspection only include a maximum of (b)(4) people, and fail to demonstrate that airflow patterns inside the ISO 5 classified critical areas are not impacted by a large number of personnel moving inside cleanroom Room (b)(4).

The FDA investigator also collected evidence indicating CGMP violations at your facility, that caused your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FDCA. The violations include, for example:

1. Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)).

2. Your firm failed to establish an adequate air supply filtered through high-efficiency particulate air filters under positive pressure in the aseptic processing areas (21 CFR 211.42(c)(10)(iii)).

3. 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).

4. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).

5. 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)). Specifically, our review of the data collected during the inspection revealed that your firm does not maintain the production video recordings which are used to determine root causes and corrective actions during investigations. For example, after recovering microbial contamination inside the ISO 5 classified critical area during the production of Ketamine HCl 10 mg/mL lot 1125035065, your Quality Unit evaluated the production video recording as part of excursion investigation EXC-2025-0045 to examine aseptic practices for potential root causes. However, instead of retaining the video recording as a quality related document, you only retained still images. Your Chief Quality Officer stated that video recordings are kept for approximately (b)(4) before being overwritten.

Outsourcing facilities must comply with CGMP requirements under section 501(a)(2)(B) of the FDCA. FDA’s regulations regarding CGMP requirements for the preparation of drug products have been established in 21 CFR parts 210 and 211. FDA intends to promulgate more specific CGMP regulations for outsourcing facilities. FDA has issued a revised draft guidance, Current Good Manufacturing Practice — Guidance for Human Drug Compounding Outsourcing Facilities under Section 503B of the FD&C Act. This draft guidance, when finalized, will describe FDA’s expectations regarding outsourcing facilities and the CGMP requirements in 21 CFR parts 210 and 211 until more specific CGMP regulations for outsourcing facilities are promulgated.

Under section 301(a) of the FDCA [21 U.S.C. § 331(a)], the introduction or delivery for introduction into interstate commerce of any drug that is adulterated is a prohibited act. Further, it is also a prohibited act under section 301(k) of the FDCA [21 U.S.C. § 331(k)] to do any act with respect to a drug, if such act is done while the drug is held for sale after shipment in interstate commerce and results in the drug being adulterated.

C. Corrective Actions

We have reviewed your facility’s responses to the Form FDA 483 dated November 21, 2025, and December 31, 2025.

Some of your corrective actions appear adequate. However, we are unable to fully evaluate some of your corrective actions due to lack of adequate supporting documentation:

1. Although you stated that you performed airflow visualization studies in all (b)(4) hoods, you did not clearly demonstrate that these studies were performed in all (b)(4) hoods during the most recent airflow visualization assessment, performed in 2025. Additionally, while you concluded that the hoods are identical and therefore functionally equivalent, this approach does not account for potential variations in the HEPA filter performance, for example, resulting from particulate accumulation over time, nor the impact of physical placement of hoods within the room—including proximity to doors, return vents, and other environmental factors that may affect airflow where production activities are occurring.

Some of your corrective actions appear deficient:

1. You did not demonstrate that the probable root cause of inadequate material sanitization had no impact on the released portions of the batch associated with microbial excursions in the ISO 5 classified areas during production. You indicated both in your investigations and in your response that your material sanitization process is robust, but also concluded that the microbial contamination was most likely due to inadequate material sanitization. 

You failed to demonstrate that microbial contamination was not present in the materials associated with the released portions of the batch. You did not demonstrate that the material sanitization process for the released portions of the batches did not include the same deficiencies as the material sanitization for the rejected portion of the batch. Further, you failed to initiate any corrective and preventative action plans to determine whether you need to improve your material sanitization process to prevent reoccurrence.

2. It appears that your visual inspection system is inadequate because you classify particulate defects as major and therefore only characterize and investigate the observed particles when the defect rate is above the major defect threshold of (b)(4)%. Extrinsic particulates should be classified as critical, and the intrinsic particulates should be evaluated based on multiple factors, including particle size and route of administration, to determine the appropriate defect classification. Your SOP ILP-001-LR, Product Inspection and Defect Classification, states, “If a DRL (Defect Rate Limit) threshold is exceeded related to ‘Particulate/material in solution,’ the particulate/material must be identified during the event.” According to your visual inspection data, you detected between (b)(4) and (b)(4) particles in (b)(4) separate lots between April 2025 and September 2025, only (b)(4) lots of which exceeded the (b)(4)% threshold for major defects. According to your Deviation log, only (b)(4) defect incidents were investigated between April 2025 and September 2025, and these were related to any Defect Rate Limit Threshold Exceedance, not just those involving particles. Therefore, you do not have an adequate system in place to ensure that you identify and appropriately investigate contaminating particles.

3. You did not commit to revising the minor defect classification for “[f]oreign (unusual) material, e.g., cardboard trapped between stopper ribs” to account for the criticality of the foreign material. While you noted that any units exhibiting this defect are rejected, the defect rate limit applied to minor defects ((b)(4)%) is not appropriate for adequately investigating, trending, and performing corrective actions, as necessary, to mitigate this contamination risk.

You did not provide adequate documentation to demonstrate that foreign materials are contained within the ribs of the syringe stoppers in non-product-contact area and will not pose contamination risks to the drug product. In addition, the syringe filling process demonstrates that the foreign material does come into contact with product-contact area of the syringes. For example, any cardboard particles trapped within the syringe ribs may be pressed against the inner syringe wall during filling, potentially introducing particles onto a surface that subsequently contacts the drug product solution.

In addition to the issues discussed above, you should note that CGMP requires the implementation of quality oversight and controls over the manufacture of drugs, including the safety of raw materials, materials used in drug manufacturing, and finished drug products. See section 501 of the FDCA. If you choose to contract with a laboratory to perform some functions required by CGMP, it is essential that you select a qualified contractor and that you maintain sufficient oversight of the contractor’s operations to ensure that it is fully CGMP compliant. Regardless of whether you rely on a contract facility, you are responsible for assuring that drugs you produce are neither adulterated nor misbranded. [See 21 CFR 210.1(b), 21 CFR 200.10(b).]

FDA strongly recommends that your management undertake a comprehensive assessment of operations, including facility design, procedures, personnel, processes, maintenance, materials, and systems. In particular, this review should assess your aseptic processing operations. A third-party consultant with relevant sterile drug manufacturing expertise should assist you in conducting this comprehensive evaluation.

D. Conclusion

The violations cited in this letter are not intended to be an all-inclusive statement of violations 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. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.

You should take prompt action to address any violations. Failure to adequately address any violations may result in legal action without further notice, including, without limitation, seizure and injunction.

Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to address any violations. Please include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. This letter notifies you of our concerns and provides you an opportunity to address them. If you believe your products are not in violation of the FDCA, include your reasoning and any supporting information for our consideration. If you cannot completely address this matter within fifteen (15) working days, state the reason for the delay and the time within which you will do so.

All correspondence should refer to the Warning Letter Number above (# 724202) and include a subject line that clearly identifies the submission as a Response to Warning Letter. If you have questions regarding the contents of this letter, please contact compoundinginspections@fda.hhs.gov.

Sincerely,
/S/

Matthew J. Lash
Acting Director
Office of Compounding Quality and Compliance
Office of Compliance
Center for Drug Evaluation and Research

cc: Scott P. Luce, Chief Executive Officer

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1 See Pub. L. No. 113-54, § 102(a), 127 Stat. 587, 587-588 (2013).