F.H. I nvestments Inc.
Form 483 issued November 8, 2024 · Bi rmi ngham, Alabama
- Inspection
- Oct 28 – Nov 8, 2024
- Investigator
- Jolanna A. Norton
- Observations
- 5
- Pages
- 7
- FEI number
- 3010348724
In short: On November 8, 2024, FDA issued a Form 483 with 5 observations to F.H. I nvestments Inc. in Bi rmi ngham, Alabama (FEI 3010348724) after an inspection that ran Oct 28 – Nov 8, 2024. The investigator was Jolanna A. Norton. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 02
Each batch of controlled-release dosage form drug product is not laboratory tested to determine conformance to…
- 03
Equipment and utensils are not cleaned, maintained and sanitized at appropriate intervals to prevent contamination that…
- 04
Separate or defined areas to prevent contamination or mix-ups are deficient regarding the…
This inspection in context
Jolanna A. Norton
22 documents · 2017–2026
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in California.
The firmF.H. I nvestments Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at F.H. I nvestments Inc.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected F.H. I nvestments Inc.?
Jolanna A. Norton is named on this Form 483, for the inspection of Oct 28 – Nov 8, 2024. Each investigator has a profile showing what they cite most.
When was F.H. I nvestments Inc. inspected by FDA?
The inspection ran Oct 28 – Nov 8, 2024, and the Form 483 is dated November 8, 2024.
How do I get the full Form 483 for F.H. I nvestments Inc.?
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.