Option Care Enterprises Inc.
FDA inspection history in Everett, Washington, 2016 to 2017
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2016: one warning letter and one Form 483; 2017: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–17Two Form 483s and one warning letter, at Everett, Washington.
- 2017The longest 483 on file: 8 observations over 5 pages at Everett, Washington.
Cited most
Across all Option Care Enterprises observations on file
- 21 CFR 211.42Design and construction features5
- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.56Sanitation2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.130Packaging and labeling operations1
The complete Option Care Enterprises file.
All 3 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
Everett, Washington
Two Form 483s and one warning letter · 2016 to 2017 · 15 observations
Latest: Form 483, May 18, 2017 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-05-18 | 483 Form 483 | Everett, Washington | 8 | $99 |
| 2016-09-07 | Warning letter Warning letter | Everett, Washington | — | $99 |
| 2016-02-25 | 483 Form 483 | Everett, Washington | 7 | $99 |
Investigators on these documents
Gerald A. D'amico (1)Mark B. Rapoport (1)Sarah M. Krumm (1)Tracy K. Li (1)
FEI number 3009486960 · most recent document May 18, 2017
About Option Care Enterprises Inc.
How many FDA Form 483s has Option Care Enterprises Inc. received?
FDA Intel has 2 Form 483s on file for Option Care Enterprises Inc.; the most recent is dated May 18, 2017.
When was Option Care Enterprises Inc. last inspected by FDA?
The most recent FDA inspection document on file for Option Care Enterprises Inc. is a Form 483 dated May 18, 2017, for the site in Everett, Washington.
What did FDA cite at Option Care Enterprises Inc.?
The regulations cited most in the observations on file for Option Care Enterprises Inc. are 21 CFR 211.42 (Design and construction features), 5 times; 21 CFR 211.113 (Control of microbiological contamination), 4 times; 21 CFR 211.56 (Sanitation), 2 times.
Has Option Care Enterprises Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Option Care Enterprises Inc.; the most recent is dated Sep 7, 2016.