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.

Does this Form 483 mean Empower Clinic Services LLC dba Empower Pharmacy violated the law?

No. A Form 483 documents an investigator's observations only. FDA reviews the firm's written response and any corrective actions taken before deciding whether further action is warranted, and many 483s are closed without additional enforcement once a firm shows adequate correction.

FDA Form 483 — Empower Clinic Services LLC dba Empower Pharmacy (November 14, 2025)

Here's the summary: FDA inspected Empower Clinic Services LLC dba Empower Pharmacy in Texas and issued a Form 483 listing 5 inspectional observations following an inspection that concluded 2025-11-14. FDA records classify Empower Clinic Services LLC dba Empower Pharmacy as a producer of sterile and non sterile drug products. 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	Empower Clinic Services LLC dba Empower Pharmacy
FEI / inspection ID	3021758709
Inspection end date	November 14, 2025
Citation count	5

Citations explained

Observation 1 — Microbial contamination was present in the ISO fl', area

Microbial contamination was present in the ISO fl', area. Specifically, during a review of selected non-confo1mance repo1is, NC- 00230)0Cbdocmnije nted on August 21, 2024, at approximately 0925, a viable a ir sample collected from Location (b)(4) witlll_l ISO Class [(6)(4 6 ) ]F illing Room 1267 recover ed one (I) colony-fo1ming unit (CFU during routine )("4 1 environmental monitoring (EM) activities (exceed action limit of(6)(4) J for ISO fl', environments). Testosterone CYJ)ionate in GSO Injection, 200 m g/mL (5 mL fill volume ., Lot #202364, BUD 5/28/2025, Qty. 4 (b) ( ) vials was being filled using the ((b) (4) _, IFiller. Your fnm failed to adequately control microbial contamination within your fnm's ISO I rooms. Your fnm's investigation documented the microbial was introduced by a technician introducing the contamination by hand or body positioning during setup in the ISO environmen t: or from an operator be ing in close proximity to the sampling site while perfo1ming an aseptic intervention..

Observation 2 — Failure to appropriately and regularly clean and disinfect or sterilize equipment located

Failure to appropriately and regularly clean and disinfect or sterilize equipment located in the ISO 1 area. Specifically, EMPLOY EE($) SI GNATURE DATE lSSUEO SEE REVERSE Camers on E Moore, Investigat o r 11/1 4/2025 OF THIS PAGE Ol u wasef unm Agba nigo , Investigat o r ~EMOOre: X .- SIO'aed9r.c:emincinE.MOOre:· 0e11ear,>e« -1~ :ms MS12S

Observation 3 — EM PLOYEE(S) SIGNATURE SEE REVERSE Camerson E Moore, Investigator 4/2025 OF THIS

EM PLOYEE(S) SIGNATURE SEE REVERSE Camerson E Moore, Investigator 4/2025 OF THIS PAGE Oluwasefunm Agbanigo, Investigator - DATE lSSUEO 11 / 1 ~EMOOre: SIO'aed9r.c:emincinE.MOOre:· X ~~ 1..-ns ws12S

Observation 4 — Personnel were observed moving quickly in a critical area or in an

Personnel were observed moving quickly in a critical area or in an area immediately a dj acent to a critical ar ea likely caus ing disrnption of unidirectional airflow. Specifically, during observations of the[ ~,2]4) JFiller production equipment setup, sterile batch filling/capping, and cleaning of the sterile diu g product, Tirzepatide/ Niacinamide (4 mL) 17 / 2 mg/mL, L ot# 221077, BUD 2/1/2026, Qty. ((b) (4)] vials, technicians within the ISO[(t>l(4) I Filling Cleanroom while per fo1ming wipe down interventions of the doors and sidewalls used a rapid wipe down method (rap id back and fo1th strokes) potentially disrnpting unidirectional flow.

Observation 5 — Smoke studies were inadequately per fo1med under dynamic conditions

Smoke studies were inadequately per fo1med under dynamic conditions. Specifically, your fnm 's April 2025 ISO cleanroom smoke studies failed to include the intervention involving th eK 15} ·c4) IFiller equipment setup, sterile filling/ capping, and cleaning dis infection method used fo r wiping down unit doors and sidewalls during production of sterile diug products used a rapid wipe down method (rapid back and fo1t h strokes) potentially disrnpting EMPLOYE E($) SIG NATURE DATE lSSUEO SEE REVERSE Ca mers on E Moo re, In vestigat o r 11/1 4 / 2 0 25 OF THIS PAGE Ol u wasef unm Agba n ig o , In vestigat o r .-~EMOOre: SIO'aed 9r. c:emincinE.MOOre:· X 0e11ear,>e« -1~ :ms MS12S

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.

Empower Clinic Services LLC dba Empower Pharmacy’s FDA history

Argus HQ has recorded 1 total FDA action tied to Empower Clinic Services LLC dba Empower Pharmacy: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.

Frequently asked questions

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.
Does this Form 483 mean Empower Clinic Services LLC dba Empower Pharmacy violated the law?: No. A Form 483 documents an investigator's observations only. FDA reviews the firm's written response and any corrective actions taken before deciding whether further action is warranted, and many 483s are closed without additional enforcement once a firm shows adequate correction.

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Full FDA history for Empower Clinic Services LLC dba Empower Pharmacy

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 Form 483 — Empower Clinic Services LLC dba Empower Pharmacy (November 14, 2025) — 5 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-empower-clinic-services-llc-dba-empower-pharmacy-2025-11-14-3021758709

MLA

"FDA Form 483 — Empower Clinic Services LLC dba Empower Pharmacy (November 14, 2025) — 5 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-empower-clinic-services-llc-dba-empower-pharmacy-2025-11-14-3021758709.

Chicago

Argus HQ Research. "FDA Form 483 — Empower Clinic Services LLC dba Empower Pharmacy (November 14, 2025) — 5 Citations." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-empower-clinic-services-llc-dba-empower-pharmacy-2025-11-14-3021758709.

BibTeX

@misc{argushq_argushq_ai_483_fda_483_empower_clinic_services_llc_dba_empower_pharmacy_2025_11_14_3021758709_2025,
  title = {FDA Form 483 — Empower Clinic Services LLC dba Empower Pharmacy (November 14, 2025) — 5 Citations},
  author = {{Argus HQ Research}},
  year = {2025},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/483/fda-483-empower-clinic-services-llc-dba-empower-pharmacy-2025-11-14-3021758709},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Inspection Classification Database ↗