The Richline Group, Inc.
Form 483 issued April 16, 2025 · Tamarac, Florida
- Inspection
- Mar 24 – Apr 16, 2025
- Investigator
- Ebony D. Sanon
- Observations
- 17
- Pages
- 17
- FEI number
- 3006749547
In short: On April 16, 2025, FDA issued a Form 483 with 17 observations to The Richline Group, Inc. in Tamarac, Florida (FEI 3006749547) after an inspection that ran Mar 24 – Apr 16, 2025. The investigator was Ebony D. Sanon. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
Production & process controls and capa account for 11 of 17 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design control…
- 02
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 03
Procedures to prevent contamination of equipment or product by substances that may have an adverse effect…
- 04
Products that do not conform to specifications…
This inspection in context
Ebony D. Sanon
8 documents · 2022–2026
Cites 820.184 (device history record) more than any other section. Most of their documents are for sites in Florida.
The firmThe Richline Group, 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 820.30(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at The Richline Group, Inc.?
FDA listed 17 observations on this Form 483, mostly about production & process controls, cAPA and records & documents. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.
Who inspected The Richline Group, Inc.?
Ebony D. Sanon is named on this Form 483, for the inspection of Mar 24 – Apr 16, 2025. Each investigator has a profile showing what they cite most.
When was The Richline Group, Inc. inspected by FDA?
The inspection ran Mar 24 – Apr 16, 2025, and the Form 483 is dated April 16, 2025.
How do I get the full Form 483 for The Richline Group, Inc.?
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