Key facts
| Firm | Empower Clinic Services LLC dba Empower Pharma |
|---|---|
| FEI / inspection ID | 3011887629 |
| Inspection end date | December 14, 2025 |
| Citation count | 8 |
Citations explained
Observation 1 — Procedmes designed to prevent microbiologi cal contaminati on of diug products pmpo1iing
Procedmes designed to prevent microbiologi cal contaminati on of diug products pmpo1iing to be sterile are not established, written and followed. Specifically, A. Aseptic process simulations (APS) are not adequately designed or controlled to demonstrate that aseptic operations can consistently prevent microbiologi cal contaminati on of sterile di11g products. For example, 1. Y om aseptic orocess simulations do not encompass the full aseptic process, as fo1mulation, [(b) (4) I and [( b ) (4 Ifilling operations are perfo1med and qualified separately rather than as a single integrated simulation reflective of routine production. For example, products such as Ascorbic Acid Preserved 200 m g/mL (30 mL) require a sequential series of events, to include fo1mulati on of the bulk, transfer to [(15) (4 ) I and transfer to~ ) ( 4) I/Filling. Rather, yom cmTent APS breaks these steps into separate activities and evaluates growth or tmb idity only at the [(b) (4 ) !filling step, without simulating or assessing upstream.
Observation 2 — Control procedures are not established which monitor the output and validate the
Control procedures are not established which monitor the output and validate the perfo1mance of tho se manufacturing processes that may be responsible for causing variability in the characteristics of in process material and the diug product. Specifically, A. Your visual inspection program lacks adequate controls and scientific justification to ensure consistent detection and evaluation of product defects, including, but not limited to, the following: Digitally signed SEE Joohi Cas t elve t ere, Investigat o r X JOOH I byJOOlil CASTELVETERE• 11 / 1 4 /2025 REVERSE OF Muna Alghar i beh, Investigator CASTE LVs THIS PAGE ETERE -S ~;~~11 .14 18:18:0S -06'00'
Observation 3 — There is a failure to thoroughly review any unexplained discrepancy and the
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specification whether or not the batch has been ah-eady distributed. Specifically, A. Your fnm implemented a change under CHR-0000005416 to reduce the retention timeframe for aseptic operation records based on repo1ted "poor practices" and untimely investigation activities by quality personnel, however, no nonconfo1mance, or CAPA h ad been generated to document, evaluate, or substantiate these behaviors within the quality system. As a result, a quality impacting change was made without suppo1ting documentation, data, or risk assessment. B. From 08/29/2024 to present, approximately 337 of approximately 963 nonconfo1mance repo1ts (NCs) (which include nonconfo1mances, deviations, and OOSs) remained open, several of which were associated with, but not limited to, batch rejections, EM recoveries, and AQL failures related to extrinsic pa1ticles and glass defects. Film management stated that investigations are delayed due to cmTent onboarding of new.
Observation 4 — Your fnm failed to establish an adequate system for cleaning and disinfecting
Your fnm failed to establish an adequate system for cleaning and disinfecting the room and equipment to produce aseptic conditions Specifically, Per the fnm 's procedure B-SOP-STR-0004, titled "Cleaning and Disinfection of the Cleanroom", Revision 017, effective date 10/05/2025. Section 6.7.4. foll owing HD injectable fo1mulation in Room f6lr4 l, the room [(b) (4) Iand clean HD substances prior to resuming the subsequent operations as stated below: - "If injectable formulation lots consisting of different actives are scheduled to be formulated consecutively (ex: Testosterone Cypionate and Estradiol Cypionate), [(6} (.i4 ] cleaning shall be completed prior to the formulation of different active sterile injectable lots. SEE Joohi Cas t elve t ere, Inve s ti ga t o r x JOOHI Dig itally signed 11 / 1 4 /2025 REVERSE OF CASTELVbyJOOHI Muna Alghar i beh, Investigator CASTELVETERE-S Date: 2025.11.1 4 THIS PAGE ETERE -S 1s:21:01-06w FORM FDA ~83 (09/08) PREVIOUS EDmON OBSOLEJE INSPECTIONAL OB SERVATIONS PAGE 11 OF 18.
Observation 5 — The responsibilities and procedures applicable to the quality control unit are not
The responsibilities and procedures applicable to the quality control unit are not fully followed. Specifically, SEE J oo hi Cas t elve t ere, Investigat o r x JOOHI Digitally signed by 11 / 1 4 /202 5 REVERSE OF JOOHI Muna Alghar i beh, Investigator CASTELVCASTELVmRE -S THIS PAGE ETERE -S Date: 202s.11.1 4 1s,2 1:33-06'oo· FORM FDA ~83 ( 09/ 08) PREVIOUS EDmON OBSOLEJE INSPECTIONAL OB SERVATIONS PAGE 12OF 18 PAGES
Observation 6 — Time limits are not establish ed when appropriate for the completion of
Time limits are not establish ed when appropriate for the completion of each production ph ase to assure the quality of the diug product. Specifically, Your fnm fa il ed to establish validated hold-times for sterilized bulk diug products to mitigate the risk of contamination of finish ed diug p roducts. For example, The varia bility in the number of days the di11g product is held between the first[(6) (4) I and the second[(o) (4) I and filling steps of the production process is described in the foll owing tabl e: Drug product Testosterone Cypionate 200MG/ML (5 ML) Testosterone Cypionate 200MG/ML (30M L) Lot# 614993 61515 4 Formulation A End Date ...J<or(4 ~ Date b )(4 ) B Time between End of activity A and & Filling ~ (6J(4]- beginning of Date activity B 6 da ys 2.5 days SEE Joohi Cas t elve t ere, Inves t iga t or x JOOH I Digitall y signed byJOOHI 11 /.
Observation 7 — Your fnm failed to test samples of each component for identity and
Your fnm failed to test samples of each component for identity and confo1mity with all appropriate written specifications for purity, strength, and quality. Your fnm also failed to validate and establish the reliability of your component supplier 's test analyses at appropriate intervals. Specifically, SEE Joohi Cas t elve t ere, Investigat o r X JOOH I Digttallysigned 11 / 1 4 /2025 REVERSE OF Muna Alghar i beh, Investigator byJOOHI CASTELV CASTELVETERE-S THIS PAGE Date: ETERE -5 2025.11.14 1s:23:31-06w FORM FDA ~83 (09/ 08) PREVIOUS EDmON OBSOLEJE
Observation 8 — The written stability program fo r diug products does not include reliable
The written stability program fo r diug products does not include reliable, meaningful and specific test methods. Specifically, A. The methods used during stability testing have n ot been demonstrated to be stability indicating. Although limited stress studies were per fo1med by your contract laboratories, they did n ot include sufficient evaluation of degradation products or impurities. fu addition, you do not r eview the method validation data to co nfnm that these methods are stability indicating before approving and using them for stability testing. As a result, you do not ens ure that the stability methods can detect and quantify all potential impurities and degradation products that may f01m over time. SEE J oo hi Cas t elve t ere, Inves t iga t o r x JOOHI ~9 J~t :igned 11 / 1 4 /202 5 REVERSE OF Muna Alghar i beh, Invest i gator CASTELV CASTRVETERE -s THIS PAGE ET ER E-S Date:2025.11.14 18:23 :58 --06'00' FORM.
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 Pharma’s FDA history
Argus HQ has recorded 1 total FDA action tied to Empower Clinic Services LLC dba Empower Pharma: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.
Frequently asked questions
- Does this Form 483 mean Empower Clinic Services LLC dba Empower Pharma 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.
- What happens after a Form 483 is issued?
- The firm typically has 15 business days to submit a written response describing planned corrections. FDA reviews that response, and unresolved or serious findings can lead to a Warning Letter, import alert, or other enforcement action, though many 483s are resolved without further FDA action.
- Has Empower Clinic Services LLC dba Empower Pharma had other FDA inspection citations?
- This is the only FDA action Argus HQ has on file for Empower Clinic Services LLC dba Empower Pharma so far. Argus ingests new FDA records daily.
- What is the FEI / inspection ID for this Form 483?
- FEI / inspection ID: 3011887629.
See if this 483 escalates to a warning letter — before your auditor asks.
Free weekly briefing tracks every FDA inspection outcome.
Related enforcement actions
Full FDA history for Empower Clinic Services LLC dba Empower PharmaCompiled 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 Empower Clinic Services LLC dba Empower Pharma: Form 483 with 8 Citations (December 14, 2025). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-empower-clinic-services-llc-dba-empower-pharma-2025-12-14-3011887629
"FDA Inspects Empower Clinic Services LLC dba Empower Pharma: Form 483 with 8 Citations (December 14, 2025)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-empower-clinic-services-llc-dba-empower-pharma-2025-12-14-3011887629.
Argus HQ Research. "FDA Inspects Empower Clinic Services LLC dba Empower Pharma: Form 483 with 8 Citations (December 14, 2025)." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/483/fda-483-empower-clinic-services-llc-dba-empower-pharma-2025-12-14-3011887629.
@misc{argushq_argushq_ai_483_fda_483_empower_clinic_services_llc_dba_empower_pharma_2025_12_14_3011887629_2025,
title = {FDA Inspects Empower Clinic Services LLC dba Empower Pharma: Form 483 with 8 Citations (December 14, 2025)},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-empower-clinic-services-llc-dba-empower-pharma-2025-12-14-3011887629},
note = {Accessed: July 13, 2026}
}