HILL DERMACEUTICALS, INC.
Form 483 issued August 11, 2021 · SANFORD, Florida
- Inspection
- Jul 26 – Aug 11, 2021
- Investigators
- Nicole E. Knowlton· Steven A. Brettler
- Observations
- 4
- Pages
- 5
- FEI number
- 1036365
In short: On August 11, 2021, FDA issued a Form 483 with 4 observations to HILL DERMACEUTICALS, INC. in SANFORD, Florida (FEI 1036365) after an inspection that ran Jul 26 – Aug 11, 2021. The investigators were Nicole E. Knowlton and Steven A. Brettler. Most observations concern facilities & equipment and materials.
At a glance
Facilities & equipment and materials account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Buildings used in the manufacturing, processing, packing and holding of a drug product are not maintained…
- 02
Washing and toilet facilities lack…
- 03
Each lot of a component that is liable to microbiological contamination that is objectionable in view…
- 04
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Nicole E. Knowlton
36 documents · 2013–2026
Cites 211.68 (automatic, mechanical, and electronic equipment) more than any other section. Most of their documents are for sites in Florida.
The firmHILL DERMACEUTICALS, INC. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.58
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at HILL DERMACEUTICALS, INC.?
FDA listed 4 observations on this Form 483, mostly about facilities & equipment, materials and production. The opening words of each observation are shown on this page.
Who inspected HILL DERMACEUTICALS, INC.?
Nicole E. Knowlton and Steven A. Brettler are named on this Form 483, for the inspection of Jul 26 – Aug 11, 2021. Each investigator has a profile showing what they cite most.
When was HILL DERMACEUTICALS, INC. inspected by FDA?
The inspection ran Jul 26 – Aug 11, 2021, and the Form 483 is dated August 11, 2021.
How do I get the full Form 483 for HILL DERMACEUTICALS, 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.