Schering-Plough Products, LLC
Form 483 issued December 14, 2000 · Manati, Maryland
- Inspection
- Nov 9 – Dec 14, 2000
- Investigators
- Steven B. Barber· Wanda J. Torres
- Observations
- 11
- Pages
- 5
- FEI number
- 2650149
In short: On December 14, 2000, FDA issued a Form 483 with 11 observations to Schering-Plough Products, LLC in Manati, Maryland (FEI 2650149) after an inspection that ran Nov 9 – Dec 14, 2000. The investigators were Steven B. Barber and Wanda J. Torres. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 7 of 11 observations.
Most cited: 21 CFR 211.192 (5×) · 211.160 (5×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
The manufacturing process for Mometasone Furoate Active Pharmaceutical Ingredient (API) is…
- 03
The investigation conducted regarding the failure of five lots of Mometasone Furoate (MMF-E) API to meet…
- 04
Your firm's re-processing procedure for Mometasone Furoate (MMF-E)…
This inspection in context
Steven B. Barber
3 documents · 2000–2001
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 4 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 11 observations on this Form 483, mostly about quality system, laboratory controls and production. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Schering-Plough Products, LLC?
Steven B. Barber and Wanda J. Torres are named on this Form 483, for the inspection of Nov 9 – Dec 14, 2000. Each investigator has a profile showing what they cite most.
When was Schering-Plough Products, LLC inspected by FDA?
The inspection ran Nov 9 – Dec 14, 2000, and the Form 483 is dated December 14, 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.