Biomed PA Inc. dba Soleo Health
Form 483 issued July 6, 2017 · Sharon Hill, Pennsylvania
- Inspection
- Jul 6, 2017
- Investigator
- Thomas E. Friel
- Observations
- 2
- Pages
- 2
- FEI number
- 3013456913
In short: On July 6, 2017, FDA issued a Form 483 with 2 observations to Biomed PA Inc. dba Soleo Health in Sharon Hill, Pennsylvania (FEI 3013456913) after an inspection that ran Jul 6, 2017. The investigator was Thomas E. Friel. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
2 of 2 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (2×) · 211.56 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Observation 2: scanned text, readable in the full document.
This inspection in context
Thomas E. Friel
13 documents · 2013–2017
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmBiomed PA Inc. dba Soleo Health history
The site's inspection history, in date order.
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 Biomed PA Inc. dba Soleo Health?
FDA listed 2 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Biomed PA Inc. dba Soleo Health?
Thomas E. Friel is named on this Form 483, for the inspection of Jul 6, 2017. Each investigator has a profile showing what they cite most.
When was Biomed PA Inc. dba Soleo Health inspected by FDA?
The inspection ran Jul 6, 2017, and the Form 483 is dated July 6, 2017.
How do I get the full Form 483 for Biomed PA Inc. dba Soleo Health?
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.