Central Admixture Pharmacy Services, Inc.
Form 483 issued June 11, 2014 · Allentown, Pennsylvania
- Inspection
- Jun 4 – Jun 11, 2014
- Investigators
- Akilah K. Green· Anita R. Michael· Tamara L. Ely
- Observations
- 11
- Pages
- 8
- FEI number
- 3009590582
In short: On June 11, 2014, FDA issued a Form 483 with 11 observations to Central Admixture Pharmacy Services, Inc. in Allentown, Pennsylvania (FEI 3009590582) after an inspection that ran Jun 4 – Jun 11, 2014. The investigators were Akilah K. Green, Anita R. Michael and Tamara L. Ely. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by production.
What FDA observed
Preview: the opening words of each observation- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not…
- 02
Clothing of personnel engaged in the manufacturing, processing, packing, and holding of drug products is not…
- 03
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in…
- 04
The control systems necessary to prevent contamination…
This inspection in context
Akilah K. Green
1 document · 2014
Cites 211.42(b) (design and construction features) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmCentral Admixture Pharmacy Services, Inc. history
All 8 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 11 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. 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.?
Akilah K. Green, Anita R. Michael and Tamara L. Ely are named on this Form 483, for the inspection of Jun 4 – Jun 11, 2014. Each investigator has a profile showing what they cite most.
When was Central Admixture Pharmacy Services, Inc. inspected by FDA?
The inspection ran Jun 4 – Jun 11, 2014, and the Form 483 is dated June 11, 2014.
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.