SaveWay Compounding Pharmacy Inc.
Form 483 issued October 2, 2015 · Newark, Delaware
- Inspection
- Sep 1 – Oct 2, 2015
- Investigator
- Paul L. Bellamy
- Observations
- 7
- Pages
- 3
- FEI number
- 3006101483
In short: On October 2, 2015, FDA issued a Form 483 with 7 observations to SaveWay Compounding Pharmacy Inc. in Newark, Delaware (FEI 3006101483) after an inspection that ran Sep 1 – Oct 2, 2015. The investigator was Paul L. Bellamy. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Production and facilities & equipment account for 5 of 7 observations.
Most cited: 21 CFR 211.113(b) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system…
- 02
Clothing of personnel engaged in the processing of drug products is not appropriate for…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Paul L. Bellamy
4 documents · 2011–2016
Cites 211.113(b) (control of microbiological contamination) more than any other section. Most of their documents are for sites in New Jersey.
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 211.113(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at SaveWay Compounding Pharmacy Inc.?
FDA listed 7 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 SaveWay Compounding Pharmacy Inc.?
Paul L. Bellamy is named on this Form 483, for the inspection of Sep 1 – Oct 2, 2015. Each investigator has a profile showing what they cite most.
When was SaveWay Compounding Pharmacy Inc. inspected by FDA?
The inspection ran Sep 1 – Oct 2, 2015, and the Form 483 is dated October 2, 2015.
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.