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WARNING LETTER

RC Outsourcing, LLC MARCS-CMS 722877 —

Delivery Method:
Via Electronic Mail - Delivery and Read Receipt Requested
Product:
Drugs
Recipient:
Recipient Name
Raymond R. Carlson
Recipient Title
RPh Owner
RC Outsourcing, LLC

102 East Water Street
Lowellville, OH 44436-1117
United States

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

United States

WARNING LETTER
WL # 722877

March 20, 2026

Dear Mr. Carlson:

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 (FD&C Act) [21 U.S.C. § 353b]1 on October 7, 2015, and most recently on November 27, 2025. From August 18, 2025 to August 28, 2025, an FDA investigator inspected your facility, RC Outsourcing, LLC located at 102 East Water St., Lowellville, OH 44436. The investigator noted serious deficiencies in your practices for producing drug products, which put patients at risk.

FDA issued a Form FDA 483 to your facility on August 28, 2025. We reviewed your September 19, 2025, October 28, 2025, and November 21, 2025, responses to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence on December 31, 2025. FDA also acknowledges that, on September 22, 2025, your firm initiated a voluntary recall of four (4) lots of Bevacizumab 1.75 mg/0.07 mL Syringe, 0.25 mL, within expiry, due to a lack of sterility assurance. Based on this inspection, it appears you produced drugs that violate the FD&C Act.

A. Compounded Drug Products under the FD&C Act

Under section 503B(b) of the FD&C Act, 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 FD&C Act [21 U.S.C. § 355(a)], the requirement in section 502(f)(1) of the FD&C Act [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 FD&C Act [21 U.S.C. § 360eee-1] if the conditions in section 503B of the FD&C Act are met.

An outsourcing facility, which is defined in section 503B(d)(4) of the FD&C Act [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 FD&C Act, 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 FD&C Act

Adulterated Drug Products

The FDA investigator noted 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 FD&C Act. For example, the investigator observed that:

1. You exposed sterile drugs and materials to lower than ISO 5 quality air.

Specifically, your handling of container-closure system components for Povidone-Iodine Sterile Ophthalmic Solution may result in contamination. During the repackaging process, dropper bottle caps containing the applicator tips are staged (b)(4) on the surface of your ISO 5 laminar flow hood. This practice exposes critical surfaces—specifically, the interior of the dropper bottle cap and the applicator tip—to the non-sterile surface of the ISO 5 hood. Additionally, this (b)(4)

The FDA investigator also noted CGMP violations at your facility, that caused your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the FD&C Act. The violations include, for example:

1. Your firm failed to thoroughly investigate any unexplained discrepancy or the 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).

2. Your firm failed to establish an adequate system for monitoring environmental conditions in aseptic processing area (21 CFR 42(c)(10)(iv)).

3. 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 processes (21 CFR 211.113(b)).

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 drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)).

5. 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), 211.84(d)(2)).

6. Your firm failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.188).

Outsourcing facilities must comply with CGMP requirements under section 501(a)(2)(B) of the FD&C Act. 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 FD&C Act [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 a prohibited act under section 301(k) of the FD&C Act [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.

Unapproved New Drug Products

You do not have any FDA-approved applications on file for the drug products that you repackage, such as Povidone-Iodine 5% Ophthalmic Solution.2 Under sections 505(a) and 301(d) of the FD&C Act [21 U.S.C. §§ 331(d)], a new drug may not be introduced into or delivered for introduction into interstate commerce unless an application approved by FDA under section 505 of the FD&C Act is in effect for the drug. Marketing of these products, or other applicable products, without an approved application violates these provisions of the FD&C Act.3

In addition, you do not have any FDA-approved applications on file for certain other products that you manufacture, such as Bevacizumab 1.75 mg/0.07 mL, 0.25 mL Syringe. Products such as Bevacizumab 1.75 mg/0.07 mL, 0.25 mL Syringe are unapproved new drugs under section 505 of the FD&C Act [21 U.S.C. § 355(a)] and also biological products under section 351 of the Public Health Service Act (PHS Act) [42 U.S.C. § 262]. In order to lawfully market a drug that is also a biological product, a valid biologics license application (BLA) must be in effect under the PHS Act. Your biological products, such as Bevacizumab 1.75 mg/0.07 mL, 0.25 mL Syringe, are not the subject of an approved BLA. The introduction or delivery for introduction of these products into interstate commerce is prohibited under section 301(d) of the FD&C Act [21 U.S.C. § 331(d)].4

Misbranded Drug Products

You repackage drug products, such as Povidone-Iodine 5% Ophthalmic Solution, that are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use these products safely for their intended uses.

You manufacture other products, such as Bevacizumab 1.75 mg/0.07 mL, 0.25 mL Syringe, that are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layman can use this product safely for their intended uses.

Accordingly, the labeling of these products fails to bear adequate directions for their intended uses causing them to be misbranded under section 502(f)(1) of the FD&C Act.5 

Additionally, the label of a product you manufacture, Bevacizumab 1.75 mg/0.07 mL, 0.25 mL Syringe, states that the quantity or proportion of bevacizumab is 1.25 mg. However, based on the declared concentration of 25 mg/mL, the accurate quantity or proportion of bevacizumab in your 0.25 mL syringe is 1.75 mg. Under section 502(a) of the FD&C Act [21 U.S.C. § 352(a)], a drug product is misbranded if its labeling is false or misleading in any particular. Because the labeling of this drug product is false or misleading, it is misbranded under section 502(a) of the FD&C Act.

The introduction or delivery for introduction of misbranded drugs into interstate commerce is prohibited under section 301(a) of the FD&C Act. It is also a prohibited act under section 301(k) of the FD&C Act 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 misbranded.

C. Corrective Actions

We have reviewed your facility’s responses to the Form FDA 483. We acknowledge your recall of the following four (4) lots of Bevacizumab 1.75 mg/0.07 mL Syringe, 0.25 mL, within expiry, due to a lack of sterility assurance. We are unable to fully evaluate some of your corrective actions due to lack of adequate supporting documentation:

1. Regarding your firm’s failure 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 processes:

We acknowledge the actions your firm has taken in response to the failure to ensure that components of your container-closure system, used for sterile ophthalmic drug products, are handled in a manner that maintains their sterility. We note your statement that “All Betadine (povidone-iodine) production has been suspended as of 28-AUG-2025 to allow the quality unit to assess and evaluate a potential new container-closure system and the repackaging process.” While we acknowledge that temporarily suspending production of this drug product mitigates immediate risk, you have not submitted documentation describing your Quality Unit's evaluation of any process modification designed to prevent microbiological contamination. Your response did not include a timeframe for completion of this evaluation or a plan outlining the specific steps your firm will take to resolve this deficiency.

2. Regarding your firm’s failure to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality, and purity:

We acknowledge the actions your firm has taken in response to the failure to employ appropriately validated analytical methods for assay testing of active pharmaceutical ingredients (API) in the following drug products: Lidocaine 23%-Tetracaine 7% ointment (LT), Lidocaine, USP 20%-Tetracaine, USP 6%-Phenylephrine, HCl 2% ointment (LTP), Benzocaine 20%-Lidocaine 6%-Tetracaine 4% ointment (BLT), and Lidocaine HCl 2% Injection. We noted your commitment to suspend all production of drug products using bulk API powder until strength methods are validated for CGMP release testing, and that you continue working with your contract testing laboratory to develop and validate these methods. While temporarily suspending production mitigates immediate risk, we cannot fully evaluate the adequacy of your long-term corrective action plan without additional documentation. Specifically, we require fully executed analytical method validation protocols demonstrating successful method validation, including appropriately defined system suitability criteria.

3. Regarding your firm’s failure to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced:

We acknowledge the actions your firm has taken in response to the failure to consistently record the lot numbers of sterile, (b)(4) beakers ((b)(4) Sterile Beakers) and sterile(b)(4) in the batch production records for Lidocaine 2% Injection. We note your commitment to verify the accuracy and completeness of batch production records going forward. However, we cannot fully verify the adequacy of your corrective action plan due to the lack of supporting documentation, such as executed batch production records demonstrating implementation of the corrective actions. We recognize that your firm has suspended production of drug products produced from API, including Lidocaine 2% Injection. Given this production suspension, demonstrating full correction of this violation may not be feasible at this time. Therefore, the effectiveness of your corrective actions will be assessed during the next inspection of your firm.

Some of your corrective actions appear deficient:

4. Regarding your firm’s failure to thoroughly investigate any unexplained discrepancy or the failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed:

a. We acknowledge the actions taken by your firm in response to your failure to adequately investigate the sterility failure of bevacizumab, lot # 20250428-488A81, and to extend the investigation to other potentially affected batches of drug product. Your investigation, documented as Nonconformance Report-2 (NCR-2), identified a medical condition (i.e., eczema) experienced by a sterile drug production operator as the likely cause of the contamination. According to the timeline you provided, the operator in question experienced the skin condition for approximately three months (i.e., from 04/21/2025 to 07/21/2025), yet your firm did not evaluate the potential impact on other drug product batches manufactured during this period. Additionally, despite identifying the operator's medical condition as a potential root cause, you allowed the operator to continue performing aseptic operations while wearing a patch, although you failed to provide evidence supporting the effectiveness of this control measure in reducing contamination risk. In addition, while the revised SOP-28 “Out-of-Specification and Out-of-Trend Investigations” (effective 09/12/2025) now requires evaluation of all lots produced within a particular timeframe and/or by the same operator, the procedure fails to consider other variables that may contribute to such deviations or discrepancies (e.g., drug product contamination). A comprehensive investigation should evaluate common elements such as equipment, components, and personnel in an effort to determine both potential root cause(s) and the full scope of the event.

b. We acknowledge the actions taken by your firm in response to your failure to investigate numerous instances of microbial recovery from the sleeves of gowns worn by operators who enter the ISO 5 space during sterile drug production. We note that SOP-57 “Testing of Sterile Environment” (effective 07/16/2025), which was current at the time of these microbial excursions, defined the Action Limit for sleeves as “(b)(4) CFUs.” We acknowledge your intent to “change the CFU action limit to (b)(4) for sleeve monitoring” and recognize your voluntary recall of four (4) lots of drug product, each associated with the recovery of 1 CFU from the sleeve of a production operator involved in producing the respective batch.

However, your response fails to address significant elements of the violation. Although you acknowledge the failure to investigate an adverse trend in personnel monitoring results, you have not initiated a retrospective investigation into this discrepancy. Consequently, you have not identified a root cause or implemented corrective and preventive actions to prevent recurrence.

We further note that SOP-57 “Testing of Sterile Environment” (effective 07/16/2025), which was current when this violation occurred, defined an “Alert Limit” for “ISO 7 (Sleeves)” at “(b)(4) CFUs.” However, your procedures do not define the implications of meeting or exceeding an Alert Limit. Additionally, your firm has not committed to defining what constitutes an adverse “trend” or how it will analyze such data when identified. Finally, the classification of sleeve samples as “ISO 7” is inappropriate because operators' sleeves routinely enter the ISO 5 space during aseptic operations.

5. Regarding your firm’s failure to establish an adequate system for monitoring environmental conditions in aseptic processing area:

a. We acknowledge the actions your firm has taken in response to the failure to perform adequate viable air monitoring within the ISO 5 laminar flow hood during sterile drug production activities. We note your plan to (b)(4) “to provide a better representative air sample in ISO 5 conditions.” However, you have not fully implemented and documented this corrective action through batch production records and associated environmental monitoring data. Additionally, the qualification of any such equipment should include airflow visualization studies (i.e., “smoke studies”) to demonstrate that the equipment does not adversely affect laminar airflow within the ISO 5 space and, therefore, does not compromise drug product protection.

b. We acknowledge the actions your firm has taken in response to the failure to ensure that settle plates used for passive air monitoring of the ISO 5 laminar flow hood during sterile drug production are appropriately positioned to generate data representative of the ISO 5 environment during aseptic operations. We acknowledge your plan to replace (b)(4) plates with (b)(4) plates, as (b)(4) plates are not appropriate for passive air (i.e., “settle plate”) monitoring. We further note the revisions to section 5.6.2 of SOP-57 “Testing of Sterile Environment” (effective 10/15/2025), which now states, in part, that settle plates should be “placed within the ISO 5 space near the area of highest activity or critical manipulations... without obstructing airflow or work...” However, while your response indicates that plates will now be located in closer proximity to critical operations, it fails to describe the process by which these locations are determined or whether airflow visualization studies will be conducted to verify that the plates do not adversely affect airflow within the ISO 5 space.

c. We acknowledge the actions your firm has taken in response to operators' failure to properly perform personnel sampling and monitoring (i.e., gown sleeve) as part of your environmental monitoring program. We note your plans to retrain personnel on the proper technique. However, your response failed to provide evidence that personnel have been adequately retrained and are qualified to conduct personnel sampling (i.e., gown sleeve) appropriately and consistently.

6. Regarding your firm’s failure to establish the reliability of your component supplier’s test analyses (i.e., Certificates of Analysis) at appropriate intervals, as well as your failure to conduct at least one test to verify the identity of each shipment of every lot of components:

We acknowledge the actions your firm has taken in response to the failure to conduct at least one identity test on each shipment of every lot of components, including APIs. Specifically, we note the implementation of SOP-94 “Active Pharmaceutical Ingredient Identification Testing” (Version 3.0, Effective September 12, 2025). However, your procedure contains a significant gap. Section 5.1.3 states, “If a (b)(4) lot number of an API is received, it will be held in quarantine until sampling can be obtained for identity testing.” This language indicates that your procedure would permit subsequent shipments of a previously received lot to be released to production without identity testing. This approach is inadequate. The regulatory requirement is that each shipment of each lot must be subject to at least one identity test, regardless of whether that lot number has been received previously. Lastly, your response does not include a corrective action plan to address the requirement to establish the reliability of your supplier's analyses at appropriate intervals, such as (b)(4) for APIs.

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 FD&C Act. 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 FD&C Act, 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 (# 722877) 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

_______________________

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

2 The specific products repackaged by your firm are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of diseases and/or because they are intended to affect the structure or any function of the body. Further, they are “new drugs” within the meaning of section 201(p) of the FD&C Act [21 U.S.C. 321(p)] because they are not generally recognized as safe and effective for their labeled uses.

3 Drugs that are repackaged are not eligible for the exemptions for compounded drugs under sections 503A and 503B of the FD&C Act. For additional information, you may wish to review FDA’s 2017 guidance document, “Repackaging of Certain Human Drug Products by Pharmacies and Outsourcing Facilities.” More specifically, the guidance sets forth conditions under which FDA does not intend to take action against drug products repackaged by pharmacies and outsourcing facilities for certain violations of the FD&C Act. Such conditions include, but are not limited to, the label on the immediate container (primary packaging, e.g., the syringe) of repackaged products including the statement “Not for resale.”

4 Biological products subject to licensure under section 351 of the PHS Act are not eligible for the exemptions for compounded drugs under sections 503A and 503B of the FD&C Act. For additional information, you may wish to review FDA’s 2018 guidance document, “Mixing, Diluting, or Repackaging Biological Products Outside the Scope of an Approved Biologics License Application.” More specifically, the guidance sets forth conditions under which FDA does not intend to take action for certain violations of the FD&C Act when certain biological products are mixed, diluted, or repackaged in a manner not described in their approved labeling. Such conditions include, but are not limited to: (1) the label on the immediate container (primary packaging, e.g., the syringe) of mixed, diluted, or repackaged biological products including the dosage form; and (2) the mixed, diluted, or repackaged biological products are included on a report submitted to FDA each June and December identifying the drug products made by the outsourcing facility during the previous 6-month period.

5 Your repackaged and manufactured drug products are not exempted from the requirements of section 502(f)(1) of the FD&C Act by regulations issued by the FDA (see, e.g., 21 CFR 201.115).

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