Schering-Plough Products, LLC
FDA inspection history in Las Piedras, Puerto Rico, 2001
- 2
- Form 483s
Every document, by year
- Form 483
2001: two Form 483s.
The story so far
Built from the dates and citations on the documents themselves.
- 2001Two Form 483s, at Las Piedras, Puerto Rico.
- 2001The longest 483 on file: 18 observations over 6 pages at Las Piedras, Puerto Rico.
Cited most
Across all Schering-Plough Products observations on file
- 21 CFR 211.192Production record review7
- 21 CFR 211.100Written procedures; deviations6
- 21 CFR 211.160General requirements3
- 21 CFR 211.110Sampling and testing of in-process materials and drug products2
- 21 CFR 211.166Stability testing2
The complete Schering-Plough Products file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Las Piedras, Puerto Rico
Two Form 483s · 2001 · 32 observations
Latest: Form 483, Jun 5, 2001 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2001-06-05 | 483 Form 483 | Las Piedras, Puerto Rico | 18 | $99 |
| 2001-02-16 | 483 Form 483 | Las Piedras, Puerto Rico | 14 | $99 |
Investigators on these documents
Arlene M. Badillo (1)Carlos A. Medina (1)Carmelo Rosa (1)Margarita Santiago (1)Rebecca Parrilla (1)Steven B. Barber (1)
FEI number 100176708 · most recent document Jun 5, 2001
About Schering-Plough Products, LLC
How many FDA Form 483s has Schering-Plough Products, LLC received?
FDA Intel has 2 Form 483s on file for Schering-Plough Products, LLC; the most recent is dated Jun 5, 2001.
When was Schering-Plough Products, LLC last inspected by FDA?
The most recent FDA inspection document on file for Schering-Plough Products, LLC is a Form 483 dated Jun 5, 2001, for the site in Las Piedras, Puerto Rico.
What did FDA cite at Schering-Plough Products, LLC?
The regulations cited most in the observations on file for Schering-Plough Products, LLC are 21 CFR 211.192 (Production record review), 7 times; 21 CFR 211.100 (Written procedures; deviations), 6 times; 21 CFR 211.160 (General requirements), 3 times.