Key facts
| Firm | Farmakeio Outsourcing LLC |
|---|---|
| FEI / inspection ID | 3014982757 |
| Inspection end date | September 5, 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 — There is a failme to thoroughly review any unexplained discrepancy and the
There is a failme to thoroughly review any unexplained discrepancy and the failme of a batch or any of its components to meet any of its specifications whether or not the batch has been ah-eady distributed. Specifically, A. Your fnm failed to adequately investigate and initiate con ective and preventive actions for CAPA #, CAPA-2025-0002 dated 03 Apr 2025, which documents metal shavings being found during Testosterone/Triamcinolone Acetonide granulation resulting from a worn impeller shaft seal and metal fit ring. Your fum failed to identify and or confum how long the shaft and ring had been worn and or expand the investigation beyond immediately manufactured batches, and into other manufactured finished sterile implantable distributed pellets, e.g., Testosterone Pellet (Product Strengths: 200mg, Lot 3203, Expi.ty 2/17/202026; 87.5mg, Lot 3193, Expi1y 2/17/2026; 62.5mg, Lot 3180, Expi.ty 2/17/2026; & 50mg, Lot 3179, Expi.ty 2/l 7/2026) from Testosterone Granulation Lo t( o) (4) Expi.ty 2/17/2026. Additionally, your finn's metal detection system for finished pellets.
Observation 2 — Laborat01y controls do not include the establishment of scientifically sound and appropriate
Laborat01y controls do not include the establishment of scientifically sound and appropriate specifications and test procedures designed to assure that dmg products conf01m to appropriate standards of identity, strength, quality and purity. Specifically, A . During a review of your fum's batch record for Product ID# 364, Testosterone/ Triamcinolone Acetonide Pellet (200mg/40mcg), Lot# 3131, including laborato1y test chromatograms, unknown/unidentified peaks were found during sampling testing prior to and following [(b )(4 )1 - sterilization. Your fum's management reported they are aware of the unknown peaks and at the time of this inspection is working with a contract testing laborato1y to identify and dete1mine the phaimacological activity of the foreign peaks for the Testosterone/Triamcinolone Acetonide pellets. Your fum released ai1d distributed this lot and continued producing and distributing more lots of this pellet product without identifying the unknowns. B. Testosterone/Triamcinolone Acetonide Granulation 95%/0.02 % Chemical Lot[(b) (4)] Expity 1/29/2026, Qty. [(b) (4)); and L ot ~(b) (4~ Expity 2/03/2026, Qty. [(b)(4].
Observation 3 — Each batch of controlled-release dosage f01m diug product is not laboratory tested
Each batch of controlled-release dosage f01m diug product is not laboratory tested to detennine confo1mance to the specifications for the rate of release for each active ingredient. Specifically, your fnm failed to require or perfo1m dissolution test ing on each batch of controlled- release dosage f01m diug product. The di·ug product is not laborato1y tested to dete1mine confo1mance to the specifications at a rate of release fo r each active ingredient that is reproducible. At the time of this FDA inspection, your fnm failed to adequately define a dissolution specification for the following pellet product families. A. Testosterone Regular Release Pellet (Contains no Ethylcellulose excipient); Product Strengths: 200mg & 50mg; BUD 365 days. B. Testosterone Pellet (Contains Ethylcellulose excipient); Product Strengths: 200mg, 100mg, 87.5mg, 62.5mg, 50mg, 37.5mg, 25mg, & 12.5mg; BUD 365 days. C. Testosterone/ Triamcinolone Acetonide Pellet; Product Strengths: 200mg/40mcg, 100mg/20mcg, 87.5mg/17.5mcg, 62.5mg/12.5 mcg, 50mg/10mcg, 37.5mg/7.5mcg, 25mg/5mcg, & 12.5mg/2 .5 mc g; BUD 365 days. D . Estradiol Pellet;.
Observation 4 — Equipment u sed in the manufacture, process ing, packing or holding of
Equipment u sed in the manufacture, process ing, packing or holding of drng products is not of appropriate design and of adequate size to facilitate operations for its intended use. Specifically, A. Your fnm' s[(b)(4) JSystems,l(6) (4)IMetal detection System qualification failed to show the equipment is adequately designed and sized to facilit ate operations for its intended use. During a review ofyom fnm 's [(b)(4) I, Pharmaceutical Metal Detector Perfo1mance Qualification Manual, Approval Date 5/ 192025, the PQ acceptance criteria was found inadequate, and fail ed to require specifications for the test equipment and materials. For example, within Section 7.2.2, Acceptar1ce Criteria, your fnm failed to quantify (based on[(b)(4) acceptance and reject allowances fo r[(b)(4) 1, and 0Cb )(4) ttablets or test samples. Additionally, in Section 7.2.3, Test Equipment and Materials, your fnm failed to quantify how many total samples shall be used for each type (i.e. J 6)(4) J, and [(6)(4) ~ as pa1t of the production equipment qualification..
Observation 5 — Routine calibration and checking of automatic and electronic equipment is not perfo1med
Routine calibration and checking of automatic and electronic equipment is not perfo1med according to a written program designed to assure proper performance. EMPI.OYEE(S) SI GNATURE DATE ISSUED SEE REVERSE Carnerson E Moore, Investigat o r OF THIS PAG E ........~c.rcncnE.Mi:wn ...... 9/5/2025 · x ~~~~ PAGE4of5PAGES
Farmakeio Outsourcing LLC’s FDA history
Argus HQ has recorded 1 total FDA action tied to Farmakeio Outsourcing LLC: 0 warning letters, 0 recalls, 0 approval records, and 1 Form 483 inspection citation.
Frequently asked questions
- 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 Farmakeio Outsourcing LLC 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 Farmakeio Outsourcing LLC had other FDA inspection citations?
- This is the only FDA action Argus HQ has on file for Farmakeio Outsourcing LLC so far. Argus ingests new FDA records daily.
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Related enforcement actions
Full FDA history for Farmakeio Outsourcing 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 Farmakeio Outsourcing LLC: Form 483 with 5 Citations (September 5, 2025). Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-farmakeio-outsourcing-llc-2025-09-05-3014982757
"FDA Inspects Farmakeio Outsourcing LLC: Form 483 with 5 Citations (September 5, 2025)." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-farmakeio-outsourcing-llc-2025-09-05-3014982757.
Argus HQ Research. "FDA Inspects Farmakeio Outsourcing LLC: Form 483 with 5 Citations (September 5, 2025)." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-farmakeio-outsourcing-llc-2025-09-05-3014982757.
@misc{argushq_argushq_ai_483_fda_483_farmakeio_outsourcing_llc_2025_09_05_3014982757_2025,
title = {FDA Inspects Farmakeio Outsourcing LLC: Form 483 with 5 Citations (September 5, 2025)},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-farmakeio-outsourcing-llc-2025-09-05-3014982757},
note = {Accessed: July 15, 2026}
}