Summerton Drug Compounding and Dispensary
Form 483 issued October 17, 2014 · Sumter, South Carolina
- Inspection
- Oct 6 – Oct 17, 2014
- Investigator
- E. C. Gist
- Observations
- 8
- Pages
- 3
- FEI number
- 3010494410
In short: On October 17, 2014, FDA issued a Form 483 with 8 observations to Summerton Drug Compounding and Dispensary in Sumter, South Carolina (FEI 3010494410) after an inspection that ran Oct 6 – Oct 17, 2014. The investigator was E. C. Gist. Most observations concern quality system and production.
At a glance
Quality system and production account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There is a failure to thoroughly review the failure of a batch or any of its…
- 02
The written stability testing…
- 03
Blitch production and control records do not mdud c complete information relating to the production and…
- 04
Wr irtcn produt:Hon anll process control procedure~ are nor followed in the execution of…
This inspection in context
E. C. Gist
1 document · 2014
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in South Carolina.
The firmSummerton Drug Compounding and Dispensary history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Summerton Drug Compounding and Dispensary?
FDA listed 8 observations on this Form 483, mostly about quality system, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Summerton Drug Compounding and Dispensary?
E. C. Gist is named on this Form 483, for the inspection of Oct 6 – Oct 17, 2014. Each investigator has a profile showing what they cite most.
When was Summerton Drug Compounding and Dispensary inspected by FDA?
The inspection ran Oct 6 – Oct 17, 2014, and the Form 483 is dated October 17, 2014.
How do I get the full Form 483 for Summerton Drug Compounding and Dispensary?
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.