Schering-Plough Products, LLC
Form 483 issued June 5, 2001 · Las Piedras, Puerto Rico
- Inspection
- May 1 – Jun 5, 2001
- Investigators
- Arlene M. Badillo· Steven B. Barber
- Observations
- 18
- Pages
- 6
- FEI number
- 100176708
In short: On June 5, 2001, FDA issued a Form 483 with 18 observations to Schering-Plough Products, LLC in Las Piedras, Puerto Rico (FEI 100176708) after an inspection that ran May 1 – Jun 5, 2001. The investigators were Arlene M. Badillo and Steven B. Barber. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and quality system account for 13 of 18 observations.
Most cited: 21 CFR 211.100 (6×) · 211.192 (5×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You are not following the process described in the “Change Being Effected…
- 02
You have not developed validation/qualification master plans encompassing process, cleaning, computer and analytical method validation as…
- 03
Corrective actions you commited to in your response dated October 12, 1999 to the FDA-483 issued…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Arlene M. Badillo
1 document · 2001
Cites 211.100 (written procedures; deviations) 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 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Schering-Plough Products, LLC?
FDA listed 18 observations on this Form 483, mostly about production, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Schering-Plough Products, LLC?
Arlene M. Badillo and Steven B. Barber are named on this Form 483, for the inspection of May 1 – Jun 5, 2001. Each investigator has a profile showing what they cite most.
When was Schering-Plough Products, LLC inspected by FDA?
The inspection ran May 1 – Jun 5, 2001, and the Form 483 is dated June 5, 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.