Option Care Enterprises
Form 483 issued June 28, 2016 · Columbia, Maryland
- Inspection
- Jun 20 – Jun 28, 2016
- Investigator
- Djamila Harouaka
- Observations
- 5
- Pages
- 5
- FEI number
- 3012335395
In short: On June 28, 2016, FDA issued a Form 483 with 5 observations to Option Care Enterprises in Columbia, Maryland (FEI 3012335395) after an inspection that ran Jun 20 – Jun 28, 2016. The investigator was Djamila Harouaka. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
3 of 5 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Aseptic processing areas are deficient regarding the system for cleaning an d disinfecting the room and…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Clothing of personnel engaged in the processing of drug products is not appropriate for…
- 04
Procedures designed to prevent microbiological contamination of drug products purporting to be…
This inspection in context
Djamila Harouaka
15 documents · 2015–2023
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmOption Care Enterprises history
All 2 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)(v)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Option Care Enterprises?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment and production. 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?
Djamila Harouaka is named on this Form 483, for the inspection of Jun 20 – Jun 28, 2016. Each investigator has a profile showing what they cite most.
When was Option Care Enterprises inspected by FDA?
The inspection ran Jun 20 – Jun 28, 2016, and the Form 483 is dated June 28, 2016.
How do I get the full Form 483 for Option Care Enterprises?
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.