Central Admixture Pharmacy Services, Inc.
Form 483 issued November 20, 2015 · Horsham, Pennsylvania
- Inspection
- Nov 9 – Nov 20, 2015
- Investigators
- Anita R. Michael· Deborah J. Parris
- Observations
- 9
- Pages
- 5
- FEI number
- 1000307034
In short: On November 20, 2015, FDA issued a Form 483 with 9 observations to Central Admixture Pharmacy Services, Inc. in Horsham, Pennsylvania (FEI 1000307034) after an inspection that ran Nov 9 – Nov 20, 2015. The investigators were Anita R. Michael and Deborah J. Parris. 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 9 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
Clothing of personnel engaged in the manufacturing, processing, and packing of drug products is not appropriate…
- 03
The flow of components, drug product containers, closures, and drug products though the building is not…
- 04
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in…
This inspection in context
Anita R. Michael
18 documents · 2006–2020
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmCentral Admixture Pharmacy Services, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113(b)
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 facilities & equipment, production and materials. 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.?
Anita R. Michael and Deborah J. Parris are named on this Form 483, for the inspection of Nov 9 – Nov 20, 2015. Each investigator has a profile showing what they cite most.
When was Central Admixture Pharmacy Services, Inc. inspected by FDA?
The inspection ran Nov 9 – Nov 20, 2015, and the Form 483 is dated November 20, 2015.
How do I get the full Form 483 for Central Admixture Pharmacy Services, Inc.?
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