Option Care Enterprises Inc.
Form 483 issued February 25, 2016 · Everett, Washington
- Inspection
- Feb 9 – Feb 25, 2016
- Investigators
- Gerald A. D'amico· Mark B. Rapoport· Sarah M. Krumm
- Observations
- 7
- Pages
- 7
- FEI number
- 3009486960
In short: On February 25, 2016, FDA issued a Form 483 with 7 observations to Option Care Enterprises Inc. in Everett, Washington (FEI 3009486960) after an inspection that ran Feb 9 – Feb 25, 2016. The investigators were Gerald A. D'amico, Mark B. Rapoport and Sarah M. Krumm. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 5 of 7 observations.
Most cited: 21 CFR 211.42 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Aseptic processing areas are deficient regarding the system…
- 02
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 03
Clothing of personnel engaged in the manufacturing and processing of drug products is not appropriate for…
- 04
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
This inspection in context
Gerald A. D'amico
1 document · 2016
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Washington.
The firmOption Care Enterprises Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Option Care Enterprises Inc.?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production 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 Option Care Enterprises Inc.?
Gerald A. D'amico, Mark B. Rapoport and Sarah M. Krumm are named on this Form 483, for the inspection of Feb 9 – Feb 25, 2016. Each investigator has a profile showing what they cite most.
When was Option Care Enterprises Inc. inspected by FDA?
The inspection ran Feb 9 – Feb 25, 2016, and the Form 483 is dated February 25, 2016.
How do I get the full Form 483 for Option Care Enterprises Inc.?
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