Carlton's Dunwoody Pharmacy Corp.
Form 483 issued January 13, 2016 · Dunwoody, Georgia
- Inspection
- Jan 5 – Jan 13, 2016
- Investigators
- Rachael L. Cook· Tamara J. Henderson
- Observations
- 5
- Pages
- 3
- FEI number
- 3011755158
In short: On January 13, 2016, FDA issued a Form 483 with 5 observations to Carlton's Dunwoody Pharmacy Corp. in Dunwoody, Georgia (FEI 3011755158) after an inspection that ran Jan 5 – Jan 13, 2016. The investigators were Rachael L. Cook and Tamara J. Henderson. Most observations concern laboratory controls and quality system.
At a glance
3 of 5 observations on this 483 concern laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
There is no written testing program designed to assess the stability…
- 02
Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory…
- 03
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on…
- 04
The calibration of instruments is not done at suitable intervals in accordance with an established written…
This inspection in context
Rachael L. Cook
8 documents · 2016–2020
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Georgia.
The firmCarlton's Dunwoody Pharmacy Corp. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.166(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Carlton's Dunwoody Pharmacy Corp.?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, quality system and production. The opening words of each observation are shown on this page.
Who inspected Carlton's Dunwoody Pharmacy Corp.?
Rachael L. Cook and Tamara J. Henderson are named on this Form 483, for the inspection of Jan 5 – Jan 13, 2016. Each investigator has a profile showing what they cite most.
When was Carlton's Dunwoody Pharmacy Corp. inspected by FDA?
The inspection ran Jan 5 – Jan 13, 2016, and the Form 483 is dated January 13, 2016.
How do I get the full Form 483 for Carlton's Dunwoody Pharmacy Corp.?
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.