Janssen Ortho LLC
Form 483 issued March 28, 2023 · Gurabo, Puerto Rico
- Inspection
- Mar 13 – Mar 28, 2023
- Investigator
- Raquel Gonzalez Rivera
- Observations
- 3
- Pages
- 5
- FEI number
- 3002942061
In short: On March 28, 2023, FDA issued a Form 483 with 3 observations to Janssen Ortho LLC in Gurabo, Puerto Rico (FEI 3002942061) after an inspection that ran Mar 13 – Mar 28, 2023. The investigator was Raquel Gonzalez Rivera. Most observations concern quality system and facilities & equipment.
At a glance
2 of 3 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
The quality control unit lacks the responsibility and authority to reject all components…
- 02
EUPLOYEE(S) SIGNATURE There is a failure to thoroughly review the failure of a batch or any…
- 03
Equipment surfaces that contact components are reactive, additive or absorptive so as to alter the safety…
This inspection in context
Raquel Gonzalez Rivera
7 documents · 2013–2023
Cites 211.194(a) (laboratory records) 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 211.22(a)
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 quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Janssen Ortho LLC?
Raquel Gonzalez Rivera is named on this Form 483, for the inspection of Mar 13 – Mar 28, 2023. Each investigator has a profile showing what they cite most.
When was Janssen Ortho LLC inspected by FDA?
The inspection ran Mar 13 – Mar 28, 2023, and the Form 483 is dated March 28, 2023.
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.