Medi-Fare Drug & Home Health Center, Inc.
Form 483 issued June 6, 2025 · Blacksbur, South Carolina
- Inspection
- May 19 – Jun 6, 2025
- Investigator
- Robert J. Ham
- Observations
- 7
- Pages
- 8
- FEI number
- 3009925820
In short: On June 6, 2025, FDA issued a Form 483 with 7 observations to Medi-Fare Drug & Home Health Center, Inc. in Blacksbur, South Carolina (FEI 3009925820) after an inspection that ran May 19 – Jun 6, 2025. The investigator was Robert J. Ham. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 3 of 5 observations.
Most cited: 21 CFR 211.42 (2×)
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 are not…
- 03
The separate or defined areas and control systems necessary to prevent contamination…
- 04
Aseptic processing areas are deficient regarding the system…
- 06
Written records of investigations into the failure of a batch or any of its components to…
This inspection in context
Robert J. Ham
32 documents · 2012–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Missouri.
The firmMedi-Fare Drug & Home Health Center, Inc. history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medi-Fare Drug & Home Health Center, Inc.?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Medi-Fare Drug & Home Health Center, Inc.?
Robert J. Ham is named on this Form 483, for the inspection of May 19 – Jun 6, 2025. Each investigator has a profile showing what they cite most.
When was Medi-Fare Drug & Home Health Center, Inc. inspected by FDA?
The inspection ran May 19 – Jun 6, 2025, and the Form 483 is dated June 6, 2025.
How do I get the full Form 483 for Medi-Fare Drug & Home Health Center, 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.