Form FDA 483 · Issued 2025-12-19
F.H. Investments Inc dba Asteria Health — FDA Form 483 Analysis
FEI: 3038253438 · Sector: Pharmaceuticals & Sterile/OTC Drugs (Outsourcing Facility) · Lead Investigator: Rebecca M. Okafor
FDA Form 483 issued to F.H. Investments Inc dba Asteria Health (FEI 3038253438) on 2025-12-19 following an inspection of its outsourcing facility operations in Alabama. The report documents 4 inspection observations centered on Incoming Ingredient Identity Testing & COA Qualification, CAPA, Out-of-Specification (OOS) & Complaint Investigations.
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Observation-by-Observation 21 CFR Breakdown (4)
Observation #1 · 21 CFR 211.84(d)(6)
Incoming Ingredient Identity Testing & COA Qualification
REPEAT CITATION AT FACILITY
Microbiological Contamination Exam
Inspector Observation Language: "Each lot of a [component] [drug product container] [closure] that is liable to microbiological contamination that is objectionable in view of its intended use is not subjected to microbiological tests before use. Specifically, observed during inspection of F.H. Investments Inc dba Asteria Health on 2025-12-19."
Plain-English Meaning: Failure to perform at least one test to verify the identity of every incoming dietary ingredient or raw component before use, or relying on a supplier's Certificate of Analysis (COA) without first qualifying the supplier.
Standard CAPA Remediation Path: Establish SOP-QA-004 requiring FTIR/HPLC/organoleptic identity testing on 100% of incoming dietary ingredient lots and annual audit + 3-lot confirmatory testing before relying on any vendor COA.
Observation #2 · 21 CFR 211.188(b)(12)
CAPA, Out-of-Specification (OOS) & Complaint Investigations
FIRST-TIME OBSERVATION
Investigations made into any unexplained discrepancy
Inspector Observation Language: "Batch production and control records do not include the results of any investigation made into any unexplained discrepancy, whether or not the batch of drug product had already been distributed. Specifically, observed during inspection of F.H. Investments Inc dba Asteria Health on 2025-12-19."
Plain-English Meaning: Failure to thoroughly investigate unexplained batch discrepancies, Out-of-Specification lab results, or consumer complaints/adverse events and document root-cause Corrective and Preventive Actions (CAPA).
Standard CAPA Remediation Path: Deploy a closed-loop CAPA and OOS investigation SOP requiring root-cause determination within 30 business days, impact assessment on distributed lots, and effectiveness checks.
Observation #3 · 21 CFR 212.10
Personnel GMP Training, Gowning & Hygienic Practices
FIRST-TIME OBSERVATION
Lack Adequate Resources, Facilities, Equipment.
Inspector Observation Language: "You lack adequate [resources] [facilities] [equipment] to enable your personnel to perform their functions. Specifically, observed during inspection of F.H. Investments Inc dba Asteria Health on 2025-12-19."
Plain-English Meaning: Operators performing manufacturing or QA tasks without documented GMP/SOP training, or observed gowning/hygiene deviations in production rooms.
Standard CAPA Remediation Path: Maintain role-based SOP training matrices signed prior to independent floor assignment and annual cGMP refresher assessments.
Observation #4 · 21 CFR 212.60(e)
CAPA, Out-of-Specification (OOS) & Complaint Investigations
FIRST-TIME OBSERVATION
Equipment
Inspector Observation Language: "All equipment used to perform the testing is not [suitable for its intended purposes] [capable of producing valid results]. Specifically,observed during inspection of F.H. Investments Inc dba Asteria Health on 2025-12-19."
Plain-English Meaning: Failure to thoroughly investigate unexplained batch discrepancies, Out-of-Specification lab results, or consumer complaints/adverse events and document root-cause Corrective and Preventive Actions (CAPA).
Standard CAPA Remediation Path: Deploy a closed-loop CAPA and OOS investigation SOP requiring root-cause determination within 30 business days, impact assessment on distributed lots, and effectiveness checks.