Key facts
| Firm | F.H. Investments Inc dba Asteria Health |
|---|---|
| FEI / inspection ID | 3038253438 |
| Inspection end date | December 19, 2025 |
| Citation count | 8 |
Citations explained
Observation 1 — Your fnm failed to establish adequate written procedures fo r production and
Your fnm failed to establish adequate written procedures fo r production and process controls design ed to assure that the chug products have identity, strength, purity, and quality that they are pmpo1ie d or represented to possess. Specifically, Your fnm has been manufacturing and distributing implantable ho1mone pellets s ince M ay 2025 without conducting process validation. Your fnm has n ot per fo1med Per fo1mance Qualification (PQ) on any equipment used fo r chug production nor has your fnm executed Process Validation Qualification (PPQ) for any of your chug products. Your justification includes legacy data from commercial batches produced and distributed and claims of no changes to equipment, fo1mulation, and materials. However, your fnm has made changes to your manufacturing process by, fo r example: • Adding n ew equipment ( i. e., metal detectors, weight so1iers) that were not previously apaii of your manufacturing process • Changing ch11g fo1mulation in the master batch recor d. For example, chang.
Observation 2 — The responsibilities and procedures applicable to the quality control unit are not
The responsibilities and procedures applicable to the quality control unit are not in writing and fully fo llowed. Specifically, A. Your quality unit has failed to ensure appropriate oversight for changes to master batch records. For example, as paii of PRO25-035, your fnm updated the powder fo1mulation fo r Testosterone Anastrozole products. However, your quality unit failed to appropriately review and adjust the weight of[{6f( 4}7 accordingly, leading to inconect fo1mulation direction or pellet EMPLOYEE($} S/G NA TURE DATE ISSUED BEI Y Digitally si gned 12 /1 9/202 5 SEE REVERSE • by BEi Y. HE -5 Bei Y. He, I n vest ig ator OF THIS PAGE HE S Date: 2025 . 12.19 - 13: 54:35 -06'00'
Observation 3 — The quality control unit lacks authority to review production records to assure
The quality control unit lacks authority to review production records to assure that no errors have occuned and folly investigate en ors that have occmTe d. Specifically, A. Your quality unit failed to investigate the following events: • Rejected Estradiol 6mg, L ot [( o ) (21- ) Ion July 10, 20 25 , fo r "issues experienced with powder during press ing" without opening any investigation. • No investigation was conducted fo r a confnmed laborato1y out-o f- specification investigation (OOS25-004, fail ed potency testing due to broken pellet). EMPLOYEE(S) S /G NA TUR£ DATE ISSUED BEi Y. Dig itally si gne, 1 2/19/202 5 SEE REVERSE by BEi Y. HE-5 Bei Y. He , Investigato r Date: OF THIS PAGE HE-S 2025.12. 9 13:55:54 -06'0( F ORM FDA ~83 ( 09/08) PREVIOUS EDffiON OBSOLEJE INSPEC TIONAL OBSERVATIONS PAGE I 0OF 17 PAGES
Observation 4 — Aseptic processing areas are deficient in that wall are not smooth and/or
Aseptic processing areas are deficient in that wall are not smooth and/or hard surfaces that are easily cleanable. Specifically, On December 4, 2025, the FDA investigator observed that the side 1(6) (4~ containment shield of Pellet Press [(6) (,4)] is cracked, making the area difficult to decontammate and clean. Highly potent and hazardous ho1mone pellets are manufactured inside this containment system. For example: 4 • Testosterone 200mg, Lot 251000180, EXP 09/1 9/2026 (QTY(b) < >) -RELEASED 4 • Estradiol l0mg, Lot 253000132, EXP 06/1 6/2026 (QTY(b) < l) -RELEASED • Estradiol 12 .5mg, Lot 253000130, EXP 06/1 6/2026 (QTY(6J rfl) -RELEASED EMPLOYEE(S) S/GNA TUR£ DATE ISSUED 12/19/2025 Digita ll y signed SEE REVERSE BE I Y Bei nve st ig ator -S• byBEI Y.HE -S Y. He, I HE Date: OF THIS PAGE 2025.12.19 13 :56:44 -06'00' FORM FDA ~83 (09/08) PREVIOUS EDffiON OBSOLEJE
Observation 5 — Each batch of controlled-release dosage fo1m diu g product is not laborato1y
Each batch of controlled-release dosage fo1m diu g product is not laborato1y tested to dete1mine con fo1mance to the specifications fo r the rate of release fo r each active ingredient. Specifically, Your fnm 's current release testing program involving weigh t, pellet length, endotoxin, dos imeti~ nd potency testing is inadequate to ens ure the quality of solid dosage fo1ms inten de d fo r ~: -(4 ) ._J f I- Your fnm has fail ed to establish appropriate release testing specifications fo r implantable ho1mone pellets, including: • Absence of dissolution testing fo r batch release to ensure consistent diug release and prevent dose dumping, conti·ol batch variability, and quality conti·ol fo r implantable products. • Absence of hardness/friability testing fo r batch release to ens ure pellets maintain stm ctural integrity during the inten de d multi-month implantation period. 1,(a.;;:) Your fnm has released more than !til 14 Jj batches covenn • g over ,1 u (-1.
Observation 6 — Dmg products do not bear an expiration date dete1mined by appropriate stability
Dmg products do not bear an expiration date dete1mined by appropriate stability data to assure they meet applicable standards of identity, sti·ength, quality and purity at the time of use. EMPLOYEE(S) S /G NA TUR£ DATE ISSUED BEi Y Dlg lta llyslgned 1 2/ 1 9/202 5 • byBEI Y. HE -5 SEE REVERSE Date: Bei Y. He , Investigato r OF THIS PAGE -SHE 2025.12 .1 9 13:57:07 -06'00' F ORM FDA ~83 ( 09/08) PREVIOUS EDffiON OBSOLEJE INSPEC TIONAL OBSERVATIONS PAGE 13 0F 17 PAGES
Observation 7 — Appropriate conti·ols are not exercised over computers or related systems to assure
Appropriate conti·ols are not exercised over computers or related systems to assure that changes in master production and conti·ol records or other records are instituted only by authorized personne l. Specifically, During this inspection, FDA investigators observed multiple data governance and doc ument conti·o l deficiencies affecting the reliability and integrity of data used fo r batch release decisions: A. Unrestricted analytical system access where your lab manager logged into the b) (4) chromatography system on December 4, 20 25 , without user login credentials and operated under "Admin" user profile with unrestricted access to audit ti·ails, methods, and sequences deletions. Sequence repoits since M ay 20 25 show all potency testing fo r batch release was per fo1med under "admin" accounts, compromising data integrity fo r critical quality decisions. I B. Inadequate batch record and document control where enviro nmental monitoring, personnel monitoring, sampling, and visual inspection fo1ms that suppo1t batch release decisions are EMPLOYEE(S) S /G NA TUR£.
Observation 8 — The batch production and control records are deficient in that they do
The batch production and control records are deficient in that they do n ot include documentation of th accomplis hment of each significant step in manufacturing, and processing. e Specifically, Your fnm implemented metal detection testing approximately in October 2025 for each pellet batch as a coITective measure to identify metal sh avings and paiticles that h ad been found in previous batches beginning in June 2025. However, the results of these metal detection tests are n ot documente d. Additionally, when metal contamination is identified, the con taminat ed pellets and metal fr agments ai·e discarded as waste. Th e lack of metal detection documentation in batch records may impair the quality unit's capacity to make well-info1med batch release dete1minations. EMPLOYEE(S) S /G NA TUR£ DATE ISSUED BEi Y Digitallysigned 1 2/ 1 9/202 5 • byB EI Y. HE-5 SEE REVERSE Date: Bei Y. He , Investigato r OF THIS PAGE -5HE 2025.1 2 .1 9 13:58:17 -06'.
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.
F.H. Investments Inc dba Asteria Health’s FDA history
Argus HQ has recorded 1 total FDA action tied to F.H. Investments Inc dba Asteria Health: 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 F.H. Investments Inc dba Asteria Health 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 F.H. Investments Inc dba Asteria Health had other FDA inspection citations?
- This is the only FDA action Argus HQ has on file for F.H. Investments Inc dba Asteria Health so far. Argus ingests new FDA records daily.
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Related enforcement actions
Full FDA history for F.H. Investments Inc dba Asteria HealthCompiled 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). December 19, 2025 FDA Form 483 for F.H. Investments Inc dba Asteria Health — 8 Citations. Digital Empire LLC. Retrieved from https://argushq.ai/483/fda-483-f-h-investments-inc-dba-asteria-health-2025-12-19-3038253438
"December 19, 2025 FDA Form 483 for F.H. Investments Inc dba Asteria Health — 8 Citations." Argus HQ Research, Digital Empire LLC, 2025, argushq.ai/483/fda-483-f-h-investments-inc-dba-asteria-health-2025-12-19-3038253438.
Argus HQ Research. "December 19, 2025 FDA Form 483 for F.H. Investments Inc dba Asteria Health — 8 Citations." Digital Empire LLC. Accessed July 15, 2026. https://argushq.ai/483/fda-483-f-h-investments-inc-dba-asteria-health-2025-12-19-3038253438.
@misc{argushq_argushq_ai_483_fda_483_f_h_investments_inc_dba_asteria_health_2025_12_19_3038253438_2025,
title = {December 19, 2025 FDA Form 483 for F.H. Investments Inc dba Asteria Health — 8 Citations},
author = {{Argus HQ Research}},
year = {2025},
publisher = {Digital Empire LLC},
url = {https://argushq.ai/483/fda-483-f-h-investments-inc-dba-asteria-health-2025-12-19-3038253438},
note = {Accessed: July 15, 2026}
}