Schering-Plough Products, LLC
Form 483 issued February 16, 2001 · Manati, Puerto Rico
- Inspection
- Feb 1 – Feb 16, 2001
- Investigators
- Carlos A. Medina· Carols I. Medina· Jose E. Melendez
- Observations
- 10
- Pages
- 5
- FEI number
- 2650149
In short: On February 16, 2001, FDA issued a Form 483 with 10 observations to Schering-Plough Products, LLC in Manati, Puerto Rico (FEI 2650149) after an inspection that ran Feb 1 – Feb 16, 2001. The investigators were Carlos A. Medina, Carols I. Medina, Jose E. Melendez and Steven B. Barber. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and materials account for 7 of 10 observations.
Most cited: 21 CFR 211.192 (4×) · 211.84 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm can not assure the processes used to manufacture finished pharmaceutical products can consistently produce…
- 02
Observation 2: scanned text, readable in the full document.
- 03
The firm detected a "fourth spot" in the TLC identity test for…
- 04
The firm is not following their supplier qualification and audit procedures that require a audit of…
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 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 10 observations on this Form 483, mostly about quality system, materials 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?
Carlos A. Medina, Carols I. Medina, Jose E. Melendez and Steven B. Barber 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.