Cincinnati Specialty Pharmacy, LLC
Form 483 issued September 26, 2016 · West Chester, Ohio
- Inspection
- Sep 12 – Sep 26, 2016
- Investigators
- Mary Loh· Nicholas L. Paskal
- Observations
- 2
- Pages
- 2
- FEI number
- 3012729009
In short: On September 26, 2016, FDA issued a Form 483 with 2 observations to Cincinnati Specialty Pharmacy, LLC in West Chester, Ohio (FEI 3012729009) after an inspection that ran Sep 12 – Sep 26, 2016. The investigators were Mary Loh and Nicholas L. Paskal. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (1×) · 211.25 (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.
This inspection in context
Mary Loh
1 document · 2016
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Ohio.
The firmCincinnati Specialty Pharmacy, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cincinnati Specialty Pharmacy, LLC?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Cincinnati Specialty Pharmacy, LLC?
Mary Loh and Nicholas L. Paskal are named on this Form 483, for the inspection of Sep 12 – Sep 26, 2016. Each investigator has a profile showing what they cite most.
When was Cincinnati Specialty Pharmacy, LLC inspected by FDA?
The inspection ran Sep 12 – Sep 26, 2016, and the Form 483 is dated September 26, 2016.
How do I get the full Form 483 for Cincinnati Specialty Pharmacy, LLC?
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.