Central Admixture Pharmacy Services Inc.
Form 483 issued February 19, 2013 · Wallingford, Connecticut
- Inspection
- Feb 4 – Feb 19, 2013
- Investigators
- Maya M. Davis· Philip Kreiter· Ramon E. Martinez
- Observations
- 9
- Pages
- 12
- FEI number
- 3010015551
In short: On February 19, 2013, FDA issued a Form 483 with 9 observations to Central Admixture Pharmacy Services Inc. in Wallingford, Connecticut (FEI 3010015551) after an inspection that ran Feb 4 – Feb 19, 2013. The investigators were Maya M. Davis, Philip Kreiter and Ramon E. Martinez. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and laboratory controls account for 7 of 9 observations.
Most cited: 21 CFR 211.113 (4×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The firm performs numerous manual aseptic manipulations in the filling of sterile injectable drug products intended…
- 02
There is a lack of microbial reduction/control steps in the manufacturing process…
- 03
The firm's Quality Unit failed to identify, investigate, and implement permanent corrective actions after events that…
- 04
The sterile technique qualification (media fills) do not represent routine operating conditions and does not evaluate…
This inspection in context
Maya M. Davis
4 documents · 2012–2015
Cites 211.113 (control of microbiological contamination) 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 211.113
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 9 observations on this Form 483, mostly about production, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Central Admixture Pharmacy Services Inc.?
Maya M. Davis, Philip Kreiter and Ramon E. Martinez are named on this Form 483, for the inspection of Feb 4 – Feb 19, 2013. Each investigator has a profile showing what they cite most.
When was Central Admixture Pharmacy Services Inc. inspected by FDA?
The inspection ran Feb 4 – Feb 19, 2013, and the Form 483 is dated February 19, 2013.
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.