Schering-Plough Products, LLC
Form 483 issued April 13, 2000 · Manati, Puerto Rico
- Inspection
- Nov 30, 1999 – Mar 28, 2000
- Investigator
- Manuel J. Torres
- Observations
- 10
- Pages
- 5
- FEI number
- 2650149
In short: On April 13, 2000, FDA issued a Form 483 with 10 observations to Schering-Plough Products, LLC in Manati, Puerto Rico (FEI 2650149) after an inspection that ran Nov 30, 1999 – Mar 28, 2000. The investigator was Manuel J. Torres. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×) · 211.166 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to have adequate laboratory controls as follgws: a) the validation of analytical methods is not…
This inspection in context
Manuel J. Torres
1 document · 2000
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmSchering-Plough Products, LLC history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
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 Schering-Plough Products, LLC?
FDA listed 10 observations on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Schering-Plough Products, LLC?
Manuel J. Torres is named on this Form 483, for the inspection of Nov 30, 1999 – Mar 28, 2000. Each investigator has a profile showing what they cite most.
When was Schering-Plough Products, LLC inspected by FDA?
The inspection ran Nov 30, 1999 – Mar 28, 2000, and the Form 483 is dated April 13, 2000.
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.