F.H. Investments, Inc. (dba Asteria Health)
Form 483 issued December 19, 2025 · Birmingham, Alabama
- Inspection
- Dec 5 – Dec 19, 2025
- Investigator
- Bei Y. He
- Observations
- 10
- Pages
- 18
- FEI number
- 3038253438
In short: On December 19, 2025, FDA issued a Form 483 with 10 observations to F.H. Investments, Inc. (dba Asteria Health) in Birmingham, Alabama (FEI 3038253438) after an inspection that ran Dec 5 – Dec 19, 2025. The investigator was Bei Y. He. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.100 (2×) · 211.22 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to establish adequate written procedures for production and process controls designed to assure…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 03
The responsibilities and procedures applicable to the quality control unit are not in…
- 04
The quality control unit lacks authority to review production records to assure that no errors have…
This inspection in context
Bei Y. He
14 documents · 2016–2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Michigan.
The firmF.H. Investments, Inc. (dba Asteria Health) history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at F.H. Investments, Inc. (dba Asteria Health)?
FDA listed 10 observations on this Form 483, mostly about production, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected F.H. Investments, Inc. (dba Asteria Health)?
Bei Y. He is named on this Form 483, for the inspection of Dec 5 – Dec 19, 2025. Each investigator has a profile showing what they cite most.
When was F.H. Investments, Inc. (dba Asteria Health) inspected by FDA?
The inspection ran Dec 5 – Dec 19, 2025, and the Form 483 is dated December 19, 2025.
How do I get the full Form 483 for F.H. Investments, Inc. (dba Asteria Health)?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.