What is the FEI / inspection ID for this Form 483?

FEI / inspection ID: 3032314463.

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.

What is an FDA Form 483?

A Form FDA 483 lists an FDA investigator's written observations at the close of a facility inspection, issued under section 704(b) of the Federal Food, Drug, and Cosmetic Act. It documents conditions the investigator judged may violate FDA regulations. A 483 is not an enforcement action or a final determination that a violation occurred.

FDA Inspects Apothecary Pharma LLC: Form 483 with 6 Citations (May 15, 2025)

Here's the summary: FDA inspected Apothecary Pharma LLC in North Carolina and issued a Form 483 listing 6 inspectional observations following an inspection that concluded 2025-05-15. FDA records classify Apothecary Pharma LLC as a outsourcing facility. A Form 483 documents an investigator's findings at the close of an inspection under the Federal Food, Drug, and Cosmetic Act; it is not a final agency compliance determination. The observations on this page are drawn directly from the FDA-issued Form 483 record.

Key facts

Firm	Apothecary Pharma LLC
FEI / inspection ID	3032314463
Inspection end date	May 15, 2025
Citation count	6

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 — Aseptic processing areas are deficient regarding systems fo r maintaining any equipment

Aseptic processing areas are deficient regarding systems fo r maintaining any equipment used to co ntJ.·ol the aseptic conditions. Specifically, on 5/12/2025, dming production of Semaglutide Injection 2.5mg/mL Batch b)(4) I we observed the ISO 5 LFH appears to have rnst on the outside wall, unde rneath the bench, and on top panel. Additionally, the top panel of the ISO 5 LFH appeared to be dented and damaged.

Observation 2 — Aseptic process ing ar eas are deficient regarding the system fo r

Aseptic process ing ar eas are deficient regarding the system fo r cleaning and disinfecting the room and equipment to produce aseptic conditions. Specifically, on 5/12/2025, dming production of Semaglutide Injection 2.5mg/mL Batch b)(4) I we observed operator(s) EMPLOYE E($) SIG NATURE DATE lSSUEO SEE REVERSE Just i ne Toma sso , FDA Ce n ter Emplo yee 5/ 15 /202 5 OF THIS PAGE Sara h M Ga un a, FDA Ce nt er Emplo yee .-. ""'°""' T- - Xi a ohui She n , FDA Ce nt er Emp lo yee 8J(lned 8y. Jalne C. T- -8 ffi',~ os-1s-202S X

Observation 3 — Procedures designed to prevent microbiological contamination of mug products pmp o1i ing

Procedures designed to prevent microbiological contamination of mug products pmp o1i ing to be sterile did not inclu de adequate validation of the aseptic and sterilization process. Specifically, smoke studies have n ot been per fo1med under dynamic conditions to suppo1i the production and release of Cb><4 > batches of Tirzepatide l0 mg/mL. Additionally, we observed the volume and/or location of the smoke in the 11 / 25 /2024 smoke study video fo r the filling room and ISO 5 LFH appeai·ed insufficient to visualize the airflow pattern.

Observation 4 — Procedures designed to prevent microbiological contamination of mug products pmp o1iing to

Procedures designed to prevent microbiological contamination of mug products pmp o1iing to be sterile are not establish ed, written and fo llowed. Specifically, on 5/12/2025, during production of Semaglutide Injection 2.5mg/mL Batch [( 6) (~ ) I a.) we obser ved operator(s) - block fi rst air by putting their gloved hands and wrists over open ed vials during filling - fail to move with slow and deliberate movements during filling - rest their fo reaim s on the ISO 5 bench during filling - lean their heads and upper body into the hood exposing skin, from cheeks and fo rehead. EM PLOYE E($) SIGNATURE DATE lSSUEO SEE REVERSE Justine Tomasso, FDA Center Employee 5/ 1 5/2025 OF THIS PAGE Sarah M Gauna, FDA Center Employee .-.T- ""'°""' 8J(lned 8y. JalneC.- Xiaohui Shen, FDA Center Employee T--8 ffi',~os- 1s-202S X

Observation 5 — Batch production and control records do n ot include in-process and laborato1y

Batch production and control records do n ot include in-process and laborato1y control results for each batch of diug product produced. Specifically, your visual inspection program fo r the implementation and documentation of in-process controls, tests, and examin ations is inadequate. For example, the batch records fo r Tirzepatide 10 mg/mL - Batch (1:5 ) (21-) states that 12 vials were rejected out of 4 6f( that were inspected. - Batch (b)( 4) states that 11 vials were reject ed out of lhl 141 that were inspected. - Batch (b)( 4) states that 13 vials were rejected out of b) (4} that were inspected. The batch records do not specify whether rejects were due to critical, major, or minor defects or whether the acceptance criter ia fo r visual inspection defects were met. You d id n ot document complete results of 100% visual inspection, including specification of identified rejects. You did not document results of Acceptance Quality Limit (AQL).

Observation 6 — Your outsourcing facility has n ot submitted a repo1i to FDA identifying

Your outsourcing facility has n ot submitted a repo1i to FDA identifying a product compounded during the previous six months as required by section 503B(b)(2)(A) of the Federal Food, Drng, and Cosmetic Act (FD&C Act). Specifically, your outsourcing facility failed to submit an initial product repo1i to the FDA upon EM PLOYE E($) SIGNATURE DATE lSSUEO SEE REVERSE Justine Tomasso, FDA Center Employee 5/ 1 5/2025 OF THIS PAGE Sarah M Gauna, FDA Cente r Employee .-.T- ""'°""' 8J(lned 8y. JalneC.- Xia ohu i Shen, FDA Cente r Emplo yee T--8 ffi',~os- 1s-202S X PAGE4of5 PAGES

Apothecary Pharma LLC’s FDA history

Argus HQ has recorded 1 total FDA action tied to Apothecary Pharma LLC: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.

Frequently asked questions

What is the FEI / inspection ID for this Form 483?: FEI / inspection ID: 3032314463.
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.
What is an FDA Form 483?: A Form FDA 483 lists an FDA investigator's written observations at the close of a facility inspection, issued under section 704(b) of the Federal Food, Drug, and Cosmetic Act. It documents conditions the investigator judged may violate FDA regulations. A 483 is not an enforcement action or a final determination that a violation occurred.

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Full FDA history for Apothecary Pharma LLC

Compiled 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.

APA

Argus HQ Research (2025). FDA Inspects Apothecary Pharma LLC: Form 483 with 6 Citations (May 15, 2025). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-apothecary-pharma-llc-2025-05-15-3032314463

MLA

"FDA Inspects Apothecary Pharma LLC: Form 483 with 6 Citations (May 15, 2025)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-apothecary-pharma-llc-2025-05-15-3032314463.

Chicago

Argus HQ Research. "FDA Inspects Apothecary Pharma LLC: Form 483 with 6 Citations (May 15, 2025)." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-apothecary-pharma-llc-2025-05-15-3032314463.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_apothecary_pharma_llc_2025_05_15_3032314463_2025,
  title = {FDA Inspects Apothecary Pharma LLC: Form 483 with 6 Citations (May 15, 2025)},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-apothecary-pharma-llc-2025-05-15-3032314463},
  note = {Accessed: July 15, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗