Janssen Ortho LLC
Form 483 issued May 26, 2017 · Gurabo, Puerto Rico
- Inspection
- May 15 – May 26, 2017
- Investigators
- Jose A. Moreno· Jose Lopez Rubet· Noreen Muniz
- Observations
- 10
- Pages
- 11
- FEI number
- 3002942061
In short: On May 26, 2017, FDA issued a Form 483 with 10 observations to Janssen Ortho LLC in Gurabo, Puerto Rico (FEI 3002942061) after an inspection that ran May 15 – May 26, 2017. The investigators were Jose A. Moreno, Jose Lopez Rubet and Noreen Muniz. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Quality system and facilities & equipment account for 6 of 10 observations.
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Procedures describing the handling of written and oral complaints related to drug products are…
- 03
The responsibilities and procedures applicable to the quality control unit…
- 04
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
This inspection in context
Jose A. Moreno
1 document · 2017
Cites 211.160(a) (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 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Janssen Ortho LLC?
FDA listed 10 observations on this Form 483, mostly about quality system, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Janssen Ortho LLC?
Jose A. Moreno, Jose Lopez Rubet and Noreen Muniz are named on this Form 483, for the inspection of May 15 – May 26, 2017. Each investigator has a profile showing what they cite most.
When was Janssen Ortho LLC inspected by FDA?
The inspection ran May 15 – May 26, 2017, and the Form 483 is dated May 26, 2017.
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.