DCA, Inc., dba Beacon Prescriptions
Form 483 issued October 25, 2016 · Southington, Connecticut
- Inspection
- Oct 12 – Oct 18, 2016
- Investigators
- Chris Janik· John P. Mistler· Nealie C. Newberger
- Observations
- 7
- Pages
- 4
- FEI number
- 3005823862
In short: On October 25, 2016, FDA issued a Form 483 with 7 observations to DCA, Inc., dba Beacon Prescriptions in Southington, Connecticut (FEI 3005823862) after an inspection that ran Oct 12 – Oct 18, 2016. The investigators were Chris Janik, John P. Mistler and Nealie C. Newberger. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
Laboratory controls and facilities & equipment account for 5 of 7 observations.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Equipment and utensils are not cleaned and sanitized at appropriate intervals to prevent contamination that would…
- 02
The flow ofcomponents, drug product containers, in process material and drug product through the building is…
- 03
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
This inspection in context
Chris Janik
1 document · 2016
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Connecticut.
The firmDCA, Inc., dba Beacon Prescriptions history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at DCA, Inc., dba Beacon Prescriptions?
FDA listed 7 observations on this Form 483, mostly about laboratory controls, facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected DCA, Inc., dba Beacon Prescriptions?
Chris Janik, John P. Mistler and Nealie C. Newberger are named on this Form 483, for the inspection of Oct 12 – Oct 18, 2016. Each investigator has a profile showing what they cite most.
When was DCA, Inc., dba Beacon Prescriptions inspected by FDA?
The inspection ran Oct 12 – Oct 18, 2016, and the Form 483 is dated October 25, 2016.
How do I get the full Form 483 for DCA, Inc., dba Beacon Prescriptions?
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.