Key facts
| Firm | Boothwyn Pharmacy LLC |
|---|---|
| FEI / inspection ID | 1000076625 |
| Inspection end date | June 9, 2025 |
| Citation count | 5 |
What a Form 483 means
A Form FDA 483 is issued at the close of an FDA facility inspection to list conditions an investigator observed that may violate the Federal Food, Drug, and Cosmetic Act or its implementing regulations. It reflects the investigator's professional judgment at that point in time and is not a final agency determination, an enforcement action, or proof that a violation occurred. Firms are expected to respond in writing, typically within 15 business days, describing the corrective and preventive actions they plan to take. FDA reviews that response, along with any follow-up evidence, before deciding what happens next. Many 483s are resolved through corrective action alone. When FDA judges a firm's response inadequate, or when the underlying conditions are serious enough, the observations documented here can lead to a Warning Letter or further regulatory action. This page presents the observations exactly as recorded on the FDA-issued document; always confirm citation language against the original record before relying on it.
Citations explained
Observation 1 — Your firm released drug product in which the strength differs from, or
Your firm released drug product in which the strength differs from, or its purity or quality falls below, that which it purports or is represented to possess . Specifically, your firm released drug products that failed sterility or potency testing. Your firm failed to notify patients of the out of specification {00S) results. For example, lot 04072025@<b>< ◄1 TIRZEPATIDE/GLYCINE/METHYLCOBALAMIN, was produced from 04072025@'(6f(4);TIRZEPATIDE 17 MG/ML/ GLYCINE S MG/ML/ METHYLCOBALAMIN 5 MG/ML (STOCK SOLUTION) on 04/07/2025 and dispensed to patents on 04/09/2025 - 04/12/2025. Your firm received preliminary testing results on 04/11/2025 from your contracted testing laboratory indicating that there was a delay with the processing of your samples and the results were under investigation. On 04/28/2025 your firm was notified by your contract testing laboratory tha t the samples failed and were subsequently placed on hold pending an 00S investigat ion from the contract testing laboratory. The following table contains examples of some additional lots of products that were distributed.
Observation 2 — Drug held under environmental conditions whereby it may have been rendered injurious
Drug held under environmental conditions whereby it may have been rendered injurious to health. Specifically, the labels on your Semaglutide and Tirzepatide drug formulations state "store frozen" when no studies have been conducted to indicate these drugs are stable under this storage condition. The labeling for the approved drug products states, "Do not freeze and do not use if it has been frozen".
Observation 3 — Sterile drugs and materials were exposed to lower than ISO 5 quality
Sterile drugs and materials were exposed to lower than ISO 5 quality air. Specifically, A. Technician !:: was observed opening a pre-sterilized pack of vials outside of the ISO 5 area. These vials were then used to fill lot 05122025@:(b){• 8. There were multiple instances observed of Technician !>>l"~(bresting their right-hand wrist on the front vent of BSC ID 01983 during filling operations. Technician r >t•~:;rested their wrist on the vent while using the filling needle to fill vials. Once filling of a vial was completed, they would use their right hand to place stoppers, thereby removing their arm off the vent. This action of resting their right-hand wrist on the vent, removes their hand outside of ISO 5 air, which is then reintroduced into the ISOS without sanitization. C. Techniciau was observed with their hand partially outside of the BSC asset number 01984 Serial#( b) (4) when capping the first row of vials and continuing to place caps moving.
Observation 4 — Personnel were observed conducting aseptic manipulations where the movement of "first air"
Personnel were observed conducting aseptic manipulations where the movement of "first air" in the ISO 5 area is blocked or disrupted. Specifically, your production technician failed to follow asepti c technique during the production of Lot 05122025@"> Tirzepatide/Glycine/Methylcobalamin injection solution. For example, Technician '(b){6}.l\'was observed moving their left hand to the right, over the first row of uncovered vials to pick up a filling needle. Additionally, there were multiple instances where first air over open vials were blocked by the paper that is included as part of your sterile vials packaging. When Technician (b){6}. introduced the pack of vials into the ISO 5 zone, they blocked first pass air over the open packet of pre-sterilized b 4 EMPLOYEE(S EMPLOYEE{S) NAME AND TITLE (PRINT OR TYPE) DATE ISSUED ) SIGNATURE SEE REVERSE Christina K. Theodorou, Jnttf}fis~ 06/09/2025 OF THIS PAGE Evan Tong I Jnl/{onj/..lof
Observation 5 — Production areas have difficult to clean or contain porous, particle generating, or
Production areas have difficult to clean or contain porous, particle generating, or visibly dirty equipment or surfaces. Specifically, A. Your firm's ceiling tiles in PS-112 (ISO 7) where your human sterile preparations are produced, appear to be recessed so the central portion or tile is much higher than the framing making it difficult to clean . Floors, walls, and ceilings should be constructed of smooth, hard surfaces that can be easily cleaned. In addition, one of the ceiling tiles in PS-112 appears to have numerous tiny pores within the material. These factors make it difficult to clean and allow contaminants to accumulate and potentially spread. Furthermore, there are gaps in the ceiling framing that were not sealed allowing non-HEPA filtered air from the ceiling plenum to enter the ISO 7 cleanroom, where tb) <4 >1SO 5 BSCs are located and used to product drug products intended to be sterile. B. The walls in PS -112 and PS-112A are constructed of.
Boothwyn Pharmacy LLC’s FDA history
Argus HQ has recorded 2 total FDA actions tied to Boothwyn Pharmacy LLC: 0 warning letters, 0 recalls, 0 approval records, and 2 Form 483 inspection citations.
Frequently asked questions
- Has Boothwyn Pharmacy LLC had other FDA inspection citations?
- Yes. Argus HQ has recorded 2 total FDA actions tied to Boothwyn Pharmacy LLC, including 2 Form 483 inspection citations.
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 1000076625.
- Is a Form 483 the same as a Warning Letter?
- No. A Form 483 lists an FDA investigator’s observations at the close of an inspection; it is not a final agency determination. FDA may or may not follow up with a Warning Letter depending on the firm’s response and the severity of the findings.
- Where can I read the full Form 483?
- The verbatim inspection record is the source of truth — always confirm citation language against the original FDA document before acting.
See if this 483 escalates to a warning letter — before your auditor asks.
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Related enforcement actions
Full FDA history for Boothwyn Pharmacy LLCCompiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder
Cite this record
Reusing this data in reporting or research? Here’s a ready-made citation.
Argus HQ Research (2025). FDA Inspects Boothwyn Pharmacy LLC: Form 483 with 5 Citations (June 9, 2025). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-boothwyn-pharmacy-llc-2025-06-09-1000076625
"FDA Inspects Boothwyn Pharmacy LLC: Form 483 with 5 Citations (June 9, 2025)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-boothwyn-pharmacy-llc-2025-06-09-1000076625.
Argus HQ Research. "FDA Inspects Boothwyn Pharmacy LLC: Form 483 with 5 Citations (June 9, 2025)." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-boothwyn-pharmacy-llc-2025-06-09-1000076625.
@misc{argushq_argushq_ai_483_fda_483_boothwyn_pharmacy_llc_2025_06_09_1000076625_2025,
title = {FDA Inspects Boothwyn Pharmacy LLC: Form 483 with 5 Citations (June 9, 2025)},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-boothwyn-pharmacy-llc-2025-06-09-1000076625},
note = {Accessed: July 15, 2026}
}