F.H. I nvestments Inc.
Form 483 issued July 10, 2018 · Birmingham, Alabama
- Inspection
- Jun 12 – Jul 10, 2018
- Investigator
- Samantha J. Bradley
- Observations
- 4
- Pages
- 2
- FEI number
- 3010348724
In short: On July 10, 2018, FDA issued a Form 483 with 4 observations to F.H. I nvestments Inc. in Birmingham, Alabama (FEI 3010348724) after an inspection that ran Jun 12 – Jul 10, 2018. The investigator was Samantha J. Bradley. Most observations concern production and laboratory controls.
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
- 03
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
- 04
There is a failure to thoroughly review the failure of a batch or any of its…
This inspection in context
Samantha J. Bradley
14 documents · 2013–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Alabama.
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 211.113
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 4 observations on this Form 483, mostly about production, laboratory controls and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected F.H. I nvestments Inc.?
Samantha J. Bradley is named on this Form 483, for the inspection of Jun 12 – Jul 10, 2018. Each investigator has a profile showing what they cite most.
When was F.H. I nvestments Inc. inspected by FDA?
The inspection ran Jun 12 – Jul 10, 2018, and the Form 483 is dated July 10, 2018.
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.