Schering-Plough Products, LLC
FDA inspection history across 2 sites, 2000 to 2001
- 4
- Form 483s
Every document, by year
- Form 483
2000: two Form 483s; 2001: two Form 483s.
The story so far
Built from the dates and citations on the documents themselves.
- 2000–01Four Form 483s, at Manati, Maryland and Manati, Puerto Rico.
- 2001The longest 483 on file: 13 observations over 25 pages at Manati, Puerto Rico.
Cited most
Across all Schering-Plough Products observations on file
- 21 CFR 211.192Production record review9
- 21 CFR 211.160General requirements7
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.84Testing and approval or rejection of components, drug product containers, and closures3
- 21 CFR 211.110Sampling and testing of in-process materials and drug products2
The complete Schering-Plough Products file.
All 4 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
Manati, Puerto Rico
Three Form 483s · 2000 to 2001 · 33 observations
Latest: Form 483, Jun 13, 2001 →Manati, Maryland
One Form 483 · 2000 · 11 observations
Latest: Form 483, Dec 14, 2000 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2001-06-13 | 483 Form 483 | Manati, Puerto Rico | 13 | $99 |
| 2001-02-16 | 483 Form 483 | Manati, Puerto Rico | 10 | $99 |
| 2000-12-14 | 483 Form 483 | Manati, Maryland | 11 | $99 |
| 2000-04-13 | 483 Form 483 | Manati, Puerto Rico | 10 | $99 |
Investigators on these documents
Steven B. Barber (2)Carmelo Rosa (1)Carols I. Medina (1)Ileana Barreto-Pettit (1)Ivis L. Negron (1)Jose E. Melendez (1)Jose F. Pedr (1)Manuel J. Torres (1)Carlos A. Medina (1)Wanda J. Torres (1)
FEI number 2650149 · most recent document Jun 13, 2001
About Schering-Plough Products, LLC
How many FDA Form 483s has Schering-Plough Products, LLC received?
FDA Intel has 4 Form 483s on file for Schering-Plough Products, LLC; the most recent is dated Jun 13, 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 13, 2001, for the site in Manati, 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), 9 times; 21 CFR 211.160 (General requirements), 7 times; 21 CFR 211.100 (Written procedures; deviations), 3 times.