AHC Products Inc
Form 483 issued March 29, 2022 · Winchester, Kentucky
- Inspection
- Mar 23 – Mar 29, 2022
- Investigators
- Logan T. Williams· Wen Ning Chan
- Observations
- 6
- Pages
- 5
- FEI number
- 3002745172
In short: On March 29, 2022, FDA issued a Form 483 with 6 observations to AHC Products Inc in Winchester, Kentucky (FEI 3002745172) after an inspection that ran Mar 23 – Mar 29, 2022. The investigators were Logan T. Williams and Wen Ning Chan. Most observations concern quality system and materials.
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observation- 01
Specific identification tests are not conducted on components that have been accepted based on the…
- 02
An adequate number of batches of each drug product are not tested nor are records of…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 04
Procedures designed to assure that correct labels are used for drug…
This inspection in context
Logan T. Williams
32 documents · 2020–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Kentucky.
The firmAHC Products 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 211.84(d)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AHC Products Inc?
FDA listed 6 observations on this Form 483, mostly about quality system, materials and laboratory controls. The opening words of each observation are shown on this page.
Who inspected AHC Products Inc?
Logan T. Williams and Wen Ning Chan are named on this Form 483, for the inspection of Mar 23 – Mar 29, 2022. Each investigator has a profile showing what they cite most.
When was AHC Products Inc inspected by FDA?
The inspection ran Mar 23 – Mar 29, 2022, and the Form 483 is dated March 29, 2022.
How do I get the full Form 483 for AHC Products 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.