Orsini Pharmaceutical Services, Inc. dba Orsini Healthcare
Form 483 issued July 25, 2018 · Elk Grove Village, Illinois
- Inspection
- Jul 25, 2018
- Investigator
- Brian D. Nicholson
- Observations
- 2
- Pages
- 1
- FEI number
- 3013468333
In short: On July 25, 2018, FDA issued a Form 483 with 2 observations to Orsini Pharmaceutical Services, Inc. dba Orsini Healthcare in Elk Grove Village, Illinois (FEI 3013468333) after an inspection that ran Jul 25, 2018. The investigator was Brian D. Nicholson. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
2 of 2 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Cleaning procedures for the ISO-5 LAF cabinets and the classified areas where sterile drug products are…
- 02
You produced beta-lactam drugs without providing adequate containment and segregation…
This inspection in context
Brian D. Nicholson
20 documents · 2013–2022
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.
The firmOrsini Pharmaceutical Services, Inc. dba Orsini Healthcare history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Orsini Pharmaceutical Services, Inc. dba Orsini Healthcare?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment. 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 Orsini Pharmaceutical Services, Inc. dba Orsini Healthcare?
Brian D. Nicholson is named on this Form 483, for the inspection of Jul 25, 2018. Each investigator has a profile showing what they cite most.
When was Orsini Pharmaceutical Services, Inc. dba Orsini Healthcare inspected by FDA?
The inspection ran Jul 25, 2018, and the Form 483 is dated July 25, 2018.
How do I get the full Form 483 for Orsini Pharmaceutical Services, Inc. dba Orsini Healthcare?
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.