Janssen Ortho LLC
Form 483 issued February 26, 2016 · Gurabo, Puerto Rico
- Investigator
- Noreen Muniz
- Observations
- 3
- Pages
- 3
- FEI number
- 3002942061
In short: On February 26, 2016, FDA issued a Form 483 with 3 observations to Janssen Ortho LLC in Gurabo, Puerto Rico (FEI 3002942061). The investigator was Noreen Muniz. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
3 of 3 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.67 (2×) · 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Routine maintenance of the automated control system is not performed according to a written program designed…
- 02
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 03
1. IQ/OQ protocols executed on site as described in Validation Document Pla 22 Feb 2016 are…
This inspection in context
Noreen Muniz
24 documents · 2008–2022
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmJanssen Ortho LLC history
All 9 documents on file for this site, in date order, with what was cited at each inspection.
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 Janssen Ortho LLC?
FDA listed 3 observations on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Janssen Ortho LLC?
Noreen Muniz is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Janssen Ortho LLC inspected by FDA?
This Form 483 is dated February 26, 2016.
How do I get the full Form 483 for Janssen Ortho LLC?
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.