Schering-Plough Products, LLC
Form 483 issued February 16, 2001 · Las Piedras, Puerto Rico
- Inspection
- Feb 1 – Feb 16, 2001
- Investigators
- Carlos A. Medina· Carmelo Rosa· Margarita Santiago
- Observations
- 14
- Pages
- 10
- FEI number
- 100176708
In short: On February 16, 2001, FDA issued a Form 483 with 14 observations to Schering-Plough Products, LLC in Las Piedras, Puerto Rico (FEI 100176708) after an inspection that ran Feb 1 – Feb 16, 2001. The investigators were Carlos A. Medina, Carmelo Rosa, Margarita Santiago and Rebecca Parrilla. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.184 (component, drug product container, closure, and labeling records).
At a glance
Observations span 4 systems, led by laboratory controls.
Most cited: 21 CFR 211.192 (2×) · 211.166 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your laboratory failure investigations are inadequate In that you re-test without any scientific © justification until…
- 02
Your validation process for several of your products reviewed is inadequate in that it fails to…
- 03
Your equipment cleaning SOP for the Ribavirin production line is that a mayor cleaning be executed…
- 04
Failure to implement, in…
This inspection in context
Carlos A. Medina
2 documents · 2001
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmSchering-Plough Products, LLC history
All 2 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 Schering-Plough Products, LLC?
FDA listed 14 observations on this Form 483, mostly about laboratory controls, quality system and materials. The most-cited regulation is 21 CFR 211.184 (component, drug product container, closure, and labeling records). The opening words of each observation are shown on this page.
Who inspected Schering-Plough Products, LLC?
Carlos A. Medina, Carmelo Rosa, Margarita Santiago and Rebecca Parrilla are named on this Form 483, for the inspection of Feb 1 – Feb 16, 2001. Each investigator has a profile showing what they cite most.
When was Schering-Plough Products, LLC inspected by FDA?
The inspection ran Feb 1 – Feb 16, 2001, and the Form 483 is dated February 16, 2001.
How do I get the full Form 483 for Schering-Plough Products, 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.