SaveWay Compounding Pharmacy Inc.
Form 483 issued June 22, 2017 · Newark, Delaware
- Inspection
- Jun 13 – Jun 22, 2017
- Investigator
- Anita R. Michael
- Observations
- 1
- Pages
- 1
- FEI number
- 3006101483
In short: On June 22, 2017, FDA issued a Form 483 with 1 observation to SaveWay Compounding Pharmacy Inc. in Newark, Delaware (FEI 3006101483) after an inspection that ran Jun 13 – Jun 22, 2017. The investigator was Anita R. Michael. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.42(c)(10)(iv) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
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 firmSaveWay Compounding Pharmacy Inc. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42(c)(10)(iv)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at SaveWay Compounding Pharmacy Inc.?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. 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 SaveWay Compounding Pharmacy Inc.?
Anita R. Michael is named on this Form 483, for the inspection of Jun 13 – Jun 22, 2017. Each investigator has a profile showing what they cite most.
When was SaveWay Compounding Pharmacy Inc. inspected by FDA?
The inspection ran Jun 13 – Jun 22, 2017, and the Form 483 is dated June 22, 2017.
How do I get the full Form 483 for SaveWay Compounding Pharmacy 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.