Janssen-Cilag Manufacturing, LLC
Form 483 issued November 23, 2021 · Gurabo, Puerto Rico
- Inspection
- Oct 26 – Nov 23, 2021
- Investigators
- Jose E. Melendez· Marian E. Ramirez· Miguel A. Martinez
- Observations
- 13
- Pages
- 27
- FEI number
- 3006244497
In short: On November 23, 2021, FDA issued a Form 483 with 13 observations to Janssen-Cilag Manufacturing, LLC in Gurabo, Puerto Rico (FEI 3006244497) after an inspection that ran Oct 26 – Nov 23, 2021. The investigators were Jose E. Melendez, Marian E. Ramirez and Miguel A. Martinez. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 3 systems, led by laboratory controls.
Most cited: 21 CFR 211.160 (3×) · 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality…
- 02
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 03
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate sampling plans and test…
This inspection in context
Jose E. Melendez
44 documents · 2001–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmJanssen-Cilag Manufacturing, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Janssen-Cilag Manufacturing, LLC?
FDA listed 13 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Janssen-Cilag Manufacturing, LLC?
Jose E. Melendez, Marian E. Ramirez and Miguel A. Martinez are named on this Form 483, for the inspection of Oct 26 – Nov 23, 2021. Each investigator has a profile showing what they cite most.
When was Janssen-Cilag Manufacturing, LLC inspected by FDA?
The inspection ran Oct 26 – Nov 23, 2021, and the Form 483 is dated November 23, 2021.
How do I get the full Form 483 for Janssen-Cilag Manufacturing, LLC?
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