Professional Specialties Co Inc
Form 483 issued October 21, 2022 · Memphis, Tennessee
- Inspection
- Oct 17 – Oct 21, 2022
- Investigator
- Nikki S. Bryant
- Observations
- 2
- Pages
- 5
- FEI number
- 1043615
In short: On October 21, 2022, FDA issued a Form 483 with 2 observations to Professional Specialties Co Inc in Memphis, Tennessee (FEI 1043615) after an inspection that ran Oct 17 – Oct 21, 2022. The investigator was Nikki S. Bryant. Most observations concern cAPA and management controls; the most-cited regulation is 21 CFR 820.90 (nonconforming product).
At a glance
CAPA and management controls account for 2 of 2 observations.
Most cited: 21 CFR 820.90(b)(2) (1×) · 820.22 (1×)
What FDA observed
Preview: the opening words of each observation- 01
Rework and reevaluation activities have not been documented in…
- 02
Quality audits have not…
This inspection in context
Nikki S. Bryant
3 documents · 2022–2025
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in Georgia.
The firmProfessional Specialties Co Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.90(b)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Professional Specialties Co Inc?
FDA listed 2 observations on this Form 483, mostly about cAPA and management controls. The most-cited regulation is 21 CFR 820.90 (nonconforming product). The opening words of each observation are shown on this page.
Who inspected Professional Specialties Co Inc?
Nikki S. Bryant is named on this Form 483, for the inspection of Oct 17 – Oct 21, 2022. Each investigator has a profile showing what they cite most.
When was Professional Specialties Co Inc inspected by FDA?
The inspection ran Oct 17 – Oct 21, 2022, and the Form 483 is dated October 21, 2022.
How do I get the full Form 483 for Professional Specialties Co 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.