Profarrna Distribution LLC
Form 483 issued May 5, 2016 · Whitehall, Ohio
- Inspection
- Apr 5 – May 5, 2016
- Investigators
- Denise R. Pinkerton· Javonica F. Penn· Michael D. Thatcher
- Observations
- 13
- Pages
- 4
- FEI number
- 3012241066
In short: On May 5, 2016, FDA issued a Form 483 with 13 observations to Profarrna Distribution LLC in Whitehall, Ohio (FEI 3012241066) after an inspection that ran Apr 5 – May 5, 2016. The investigators were Denise R. Pinkerton, Javonica F. Penn, Michael D. Thatcher and Ucheabuchi C. Chudi-Nwankwor. Most observations concern quality system and packaging & labeling; the most-cited regulation is 21 CFR 211.150 (distribution procedures).
At a glance
Quality system and packaging & labeling account for 8 of 13 observations.
Most cited: 21 CFR 211.150 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is no quality…
- 02
OTC products packaged for retail…
- 03
Batch production and control records are not prepared for each batch…
- 04
Procedures designed to assure that correct labeling and packaging materials are used for drug…
This inspection in context
Denise R. Pinkerton
1 document · 2016
Cites 211.150 (distribution procedures) more than any other section. Most of their documents are for sites in Ohio.
The firmProfarrna Distribution LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.150
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Profarrna Distribution LLC?
FDA listed 13 observations on this Form 483, mostly about quality system, packaging & labeling and materials. The most-cited regulation is 21 CFR 211.150 (distribution procedures). The opening words of each observation are shown on this page.
Who inspected Profarrna Distribution LLC?
Denise R. Pinkerton, Javonica F. Penn, Michael D. Thatcher and Ucheabuchi C. Chudi-Nwankwor are named on this Form 483, for the inspection of Apr 5 – May 5, 2016. Each investigator has a profile showing what they cite most.
When was Profarrna Distribution LLC inspected by FDA?
The inspection ran Apr 5 – May 5, 2016, and the Form 483 is dated May 5, 2016.
How do I get the full Form 483 for Profarrna Distribution 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.