WARNING LETTER
Boothwyn Pharmacy, LLC MARCS-CMS 717525 —
- Delivery Method:
- VIA Electronic Mail
- Product:
- Drugs
- Recipient:
-
Recipient NameJohn Howell
-
Recipient TitleExecutive Vice President
- Boothwyn Pharmacy, LLC
221 Gale Lane
Kennett Square, PA 19348
United States
- Issuing Office:
- Center for Drug Evaluation and Research (CDER)
United States
WARNING LETTER
WL # 717525
January 16, 2026
Dear Mr. Howell:
From May 12, 2025, to June 9, 2025, U.S. Food and Drug Administration (FDA) investigators inspected your facility, Boothwyn Pharmacy, LLC, located at 221 Gale Lane, Kennett Square, PA 19348. During the inspection, the investigators noted serious deficiencies in your practices for producing drug products, which put patients at risk.
FDA issued a Form FDA 483 to your firm on June 9, 2025. FDA acknowledges receipt of your facility’s responses, dated July 1, 2025, and July 31, 2025. FDA further acknowledges that on July 9, 2025, your firm initiated a voluntary recall of all drug products, within expiry, with out-of-specification (OOS) results, including all drug product lots/sub lots that were filled from the same bulk stock solution. FDA also acknowledges that you ceased production of all GLP-1 drug products intended to be sterile and, on August 20, 2025, notified FDA of an intent to resume production of such products. Based on this inspection, it appears that you produced drug products that violate the Federal Food, Drug, and Cosmetic Act (FDCA).
A. Compounded Drug Products Under the FDCA
Section 503A of the FDCA describes the conditions under which human drug products compounded by a licensed pharmacist in a State licensed pharmacy or a Federal facility, or a licensed physician, qualify for exemptions from three sections of the FDCA: compliance with current good manufacturing practice (CGMP) (section 501(a)(2)(B)); labeling with adequate directions for use (section 502(f)(1)); and FDA approval prior to marketing (section 505) [21 U.S.C. §§ 351(a)(2)(B), 352(f)(1) and 355(a)].
B. Violations of the FDCA
Adulterated Drug Products
The FDA investigators 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 FDCA. For example, the investigators observed that:
1. Your firm failed to perform adequate smoke studies under dynamic conditions to demonstrate unidirectional airflow within the ISO 5 area. Therefore, your products intended to be sterile are produced in an environment that may not provide adequate protection against the risk of contamination.
2. Production areas have difficult to clean or contain porous, particle generating, or visibly dirty equipment or surfaces.
Additionally, the FDA investigators noted that your firm released and distributed drug products with strengths that differed from their labeled amounts. For example, your Fluorescein 2% Ophthalmic Solution was subpotent (lots # 01242025@(b)(4), potency of 85.865% and 03272025@(b)(4), potency of 76.1475%). Under section 501(b) of the FDCA [21 U.S.C. § 351(b)], a drug is deemed to be adulterated if it purports to be or is represented as a drug the name of which is recognized in an official compendium and its strength differs from, or its quality or purity falls below, the standard set forth in such compendium. Accordingly, your Fluorescein 2% Ophthalmic Solution is adulterated under section 501(b) of FDCA.
Furthermore, the FDA investigators noted that your firm released and distributed drug products that failed sterility testing. For example, your Tirzepatide 17mg/mL / Glycine 5mg/mL / Methylcobalamin 5mg/mL Injection (lot # 04072025@(b)(4)). In addition, the investigators noted that your firm released and distributed drug products with strengths that differed from their labeled amounts. For example, your Semaglutide 2.5mg/mL Injection was subpotent (lot # 03042025@(b)(4), potency of 79.876%) and your Tirzepatide 10mg/mL Injection was subpotent (lots # 01172025@(b)(4), potency of 86.779% and 02112025@(b)(4), potency of 89.13%). Under section 501(c) of the FDCA [21 U.S.C. § 351(c)], a drug is deemed to be adulterated if it is unrecognized in an official compendium and its strength differs from, or its quality or purity falls below, that which it purports or is represented to possess. Accordingly, your Semaglutide 2.5mg/mL Injection and Tirzepatide 10mg/mL Injection are adulterated under section 501(c) of the FDCA.
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 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.
Misbranded Drug Products
The strength of compounded drugs, for example your Fluorescein 2 % Ophthalmic Solution, Semaglutide 2.5mg/mL Injection, and Tirzepatide 10mg/mL Injection, differed from and fell below their labeled strength. Under section 502(a) of the FDCA [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 these drug products is false or misleading, they are misbranded under section 502(a) of the FDCA. The introduction or delivery for introduction into interstate commerce of these drug products therefore violates section 301(a) of the FDCA. It is also a prohibited act under section 301(k) of the FDCA 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 firm’s responses to the Form FDA 483. We further acknowledge that on July 9, 2025, your firm initiated a voluntary recall of all drug products, within expiry, with OOS results, including all drug product lots/sub lots that were filled from the same bulk stock solution. We also acknowledge that you ceased production of all GLP-1 drug products intended to be sterile and, on August 20, 2025, notified FDA of an intent to resume production of such products.
Regarding your responses related to the insanitary conditions, some of your corrective actions appear adequate; however, we cannot fully evaluate the adequacy of the following corrective actions described in your response because you did not include sufficient information or supporting documentation:
1. Regarding the repeat deficiencies identified in your smoke studies, your firm indicated that new smoke studies were performed on 07/30/2025 using protocols (b)(4) and (b)(4). However, you did not provide copies of these protocols and the corresponding new smoke studies. Without this supporting documentation, your firm’s assertion that the new smoke studies demonstrate and reflect the following corrective actions cannot be verified:
a. “Updated smoke studies will clearly demonstrate that ISO 5 air is not compromised by air entering from the surrounding ISO 7 zone, using improved camera positioning and multiple angles to ensure complete visibility of the airflow boundary.”
b. “Studies will accurately reflect production practices, including the appropriate use of one or more operators when applicable, and all roles and workflows will be documented and aligned with routine compounding procedures.”
c. “First air protection over critical items such as bulk solution containers, stopper trays, and vial caps will be explicitly visualized, with clear footage showing that airflow remains unidirectional and undisturbed across all critical points.”
d. “The issues observed in videos from BSC [Biological Safety Cabinet] units CEC#01983 and CEC#02166, such as stagnant airflow, arched patterns, backflow, and handling techniques, will be rectified by updated studies conducted under revised aseptic workflows. Technician retraining and procedural modifications have already begun to address these technique-related risks.”
e. “[Camera] positioning and lighting have been optimized to ensure that first pass air is clearly visible over all active work areas, with no blind spots during critical manipulations.”
In addition, you provided aseptic visual aids (Exhibit 12a - Aseptic Visual Aids, Pg. 79) that depicted airflow patterns in the ISO 5 BSC. These visual aids showed turbulence and no first air observed in the central area near the work surface (or deck) due to the air being pulled by the front and back vents inside the BSC. Given that your firm produces the majority of drug products intended to be sterile on the deck of a BSC, it remains unclear whether your firm has assessed and modified your aseptic procedures to adequately address this airflow deficiency.
2. Regarding your production areas having surfaces that are difficult to clean or contain porous, particle generating surfaces, your firm provided several documents: the reconstruction floor plan for the remodeling of PS-112 cleanroom suite, the construction proposal and repairs punch list, and images of the ceiling tiles and walls of the newly remodeled area still under construction. However, you did not include adequate information or supporting documentation for review, including but not limited to:
a. Specification documentation of the ceiling tiles used in the remodel;
b. Documentation demonstrating these tiles are suitable for pharmaceutical use and cleaning protocols;
c. Updated cleanroom certification report; and
d. Environmental monitoring data for the remodeled cleanroom suite.
Based on the images provided in your responses, it is unclear whether the ceiling tiles were properly caulked or if gaps exist between the ceiling tiles. Additionally, it remains unclear whether these newly constructed cleanroom areas meet the standards required to support the resumption of sterile production.
While your responses indicate that the original interior walls in rooms PS-112 and PS-112A were replaced with PVC (including in the newly created room PS-114), insufficient information or supporting documentation were provided for review, including but not limited to:
a. Specification documentation for the PVC wall paneling; and
b. Documentation demonstrating that these PVC paneling are appropriate for pharmaceutical use and cleaning.
Regarding your responses related to other adulteration issues, the following corrective actions appear deficient:
1. Regarding your firm releasing drug products where strength differs from, or quality or purity falls below, that which the products purport or are represented to possess, your firm’s Standard Operating Procedures (SOP) contain conflicting provisions regarding release of drug products intended to be sterile prior to receiving final sterility testing results raising significant concerns about product quality and patient safety. In your response, you provided SOP ID: CP.GENCMPD.016.001 Compounded Sterile Preparation Batch Release which states, “(b)(4)." However, section 6.5.1 of the same SOP states, “(b)(4).” These two statements in the same SOP appear to be contradictory, and you have not provided any scientific justification for releasing ophthalmic drug products intended to be sterile prior to receiving the final sterility test results, nor clarified whether patients or prescribers will be notified of the “at risk” status. This concern is heightened given your firm’s documented history of sterility failures of drug products intended to be sterile, where patients were not notified of these failures.
Furthermore, SOP ID: CP.GENCMPD.016.002 Batch Release Record, section 6.4.2 states, “If risk release is authorized by patient or prescriber, the Lab pharmacist may retrieve the products required for that specific RX from the designated hold area.” This provision indicates that any sterile drug product may be released “at risk”, without limiting this practice to ophthalmic preparations or excluding other categories of human drug products intended to be sterile. Additionally, the procedure does not specify whether you would inform the prescribers or patients in cases where the drug product subsequently fails sterility testing. Based on these SOPs, your firm's actual policy for “at risk” product release remains unclear, creating potential compliance issues and patient safety risks.
You acknowledged that the release of compounded preparations that were OOS “reflects a deviation from [your] internal quality assurance procedures and [your] obligation to notify patients and prescribers upon discovery of any compromise to product strength, sterility, or potency.” However, you did not provide corrective actions addressing this deviation for failure to notify patients and prescribers when OOS’s were identified.
Section 6.8 SOP ID: CP.GENCMPD.016.001 states, “Any OOS results must be immediately reported to quality and the pharmacist-in-charge. Investigation and root cause analysis should be performed when applicable per SOP QA.CAPA.016.001 Variance and OOS Investigations. A recall and customer notification procedures shall be followed when applicable.” This language indicates that investigation, root cause analysis, recall, and customer notification are only required "when applicable” rather than for every OOS occurrence. In addition, the SOP lacks defined timeframes for both patient/prescriber notification and investigation procedures following OOS occurrences.
In addition, during the inspection, investigators reviewed 23 variance/OOS investigation reports from November 2024 through May 2025; none of these reports followed your SOP for investigating OOS results, and none of the investigations included documentation of contacting the patient by your firm. Of these 23, nineteen variance/OOS investigations remained open at the time of the inspection. It remains unclear whether these variance/OOS investigation reports have since been closed and whether the affected patients and/or their healthcare providers have been notified. There is no assurance that you will adhere to your own SOP procedures moving forward.
Your responses did not identify or discuss the root cause(s) for the numerous sterility and potency OOS results for your drug products intended to be sterile. Between July 2, 2024 and May 1, 2025, your firm distributed drug products intended to be sterile that failed to meet sterility and potency specifications, including (b)(4) lots with sterility failures and approximately (b)(4) lots with potency failures (for human use). Given the substantial number of OOS results at your facility, particularly potency failures, section 6.1.2 of your SOP ID: CP.GENCMPD.016.001 Compounded Sterile Preparation Batch Release states: “(b)(4).” However, this section suggests you conduct potency testing on a selective basis rather than testing every lot or sub lot that is produced.
Please be aware that section 501(a)(2)(A) of the FDCA concerning insanitary conditions applies regardless of whether drug products you compound meet the conditions of section 503A.
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 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 in which you will do so.
Your response and any questions regarding the contents of this letter should be sent to compoundinginspections@fda.hhs.gov. In your response, refer to the Warning Letter Number above (# 717525) and include a subject line that clearly identifies the submission as a Response to Warning Letter.
Sincerely,
/S/
Matthew J. Lash
Acting Director
Office of Compounding Quality and Compliance
Office of Compliance
Center for Drug Evaluation and Research