Central Admixture Pharmacy Services Inc.
Form 483 issued January 29, 2016 · Wallingford, Connecticut
- Inspection
- Dec 1, 2015 – Jan 29, 2016
- Investigators
- Jeanet McGarry· Juanita P. Versace· Mary-Jeanet McGarry
- Observations
- 7
- Pages
- 7
- FEI number
- 3010015551
In short: On January 29, 2016, FDA issued a Form 483 with 7 observations to Central Admixture Pharmacy Services Inc. in Wallingford, Connecticut (FEI 3010015551) after an inspection that ran Dec 1, 2015 – Jan 29, 2016. The investigators were Jeanet McGarry, Juanita P. Versace, Mary-Jeanet McGarry and Philip F. Istafanos. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 6 of 7 observations.
Most cited: 21 CFR 211.42 (3×) · 211.113 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding systems for maintaining any equipment used to…
- 02
Procedmes designed to prevent microbiological contamination of dmg products purpotiing to be sterile are not…
- 03
The building lacks adequate space for the orderly placement of equipment and materials to prevent mix…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Jeanet McGarry
1 document · 2016
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Connecticut.
The firmCentral Admixture Pharmacy Services Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Central Admixture Pharmacy Services Inc.?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and quality system. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Central Admixture Pharmacy Services Inc.?
Jeanet McGarry, Juanita P. Versace, Mary-Jeanet McGarry and Philip F. Istafanos are named on this Form 483, for the inspection of Dec 1, 2015 – Jan 29, 2016. Each investigator has a profile showing what they cite most.
When was Central Admixture Pharmacy Services Inc. inspected by FDA?
The inspection ran Dec 1, 2015 – Jan 29, 2016, and the Form 483 is dated January 29, 2016.
How do I get the full Form 483 for Central Admixture Pharmacy Services Inc.?
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.