SaveWay Compounding Pharmacy Inc.
FDA inspection history in Newark, Delaware, 2015 to 2018
- 2
- Form 483s
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Close-out
- Form 483
- Warning letter
2015: one Form 483; 2016: one warning letter; 2017: one Form 483; 2018: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–18Two Form 483s, one warning letter and one close-out letter, at Newark, Delaware.
- 2015The longest 483 on file: 7 observations over 3 pages at Newark, Delaware.
Cited most
Across all SaveWay Compounding Pharmacy observations on file
- 21 CFR 211.42(c)(10)(iv)Design and construction features3
- 21 CFR 211.113(b)Control of microbiological contamination2
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.192Production record review1
- 21 CFR 211.28(a)Personnel responsibilities1
The complete SaveWay Compounding Pharmacy file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Newark, Delaware
Two Form 483s, one close-out letter and one warning letter · 2015 to 2018 · 8 observations
Latest: Close-out, Mar 28, 2018 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-03-28 | Close-out Close-out letter | Newark, Delaware | — | $99 |
| 2017-06-22 | 483 Form 483 | Newark, Delaware | 1 | $99 |
| 2016-10-04 | Warning letter Warning letter | Newark, Delaware | — | $99 |
| 2015-10-02 | 483 Form 483 | Newark, Delaware | 7 | $99 |
Investigators on these documents
FEI number 3006101483 · most recent document Mar 28, 2018
About SaveWay Compounding Pharmacy Inc.
How many FDA Form 483s has SaveWay Compounding Pharmacy Inc. received?
FDA Intel has 2 Form 483s on file for SaveWay Compounding Pharmacy Inc.; the most recent is dated Jun 22, 2017.
When was SaveWay Compounding Pharmacy Inc. last inspected by FDA?
The most recent FDA inspection document on file for SaveWay Compounding Pharmacy Inc. is a Form 483 dated Jun 22, 2017, for the site in Newark, Delaware.
What did FDA cite at SaveWay Compounding Pharmacy Inc.?
The regulations cited most in the observations on file for SaveWay Compounding Pharmacy Inc. are 21 CFR 211.42(c)(10)(iv) (Design and construction features), 3 times; 21 CFR 211.113(b) (Control of microbiological contamination), 2 times; 21 CFR 211.166(a) (Stability testing), 1 time.
Has SaveWay Compounding Pharmacy Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for SaveWay Compounding Pharmacy Inc.; the most recent is dated Oct 4, 2016.