Schering-Plough Products, LLC
Form 483 issued June 13, 2001 · Manati, Puerto Rico
- Inspection
- May 1 – Jun 13, 2001
- Investigators
- Carmelo Rosa· Ileana Barreto-Pettit· Ivis L. Negron
- Observations
- 13
- Pages
- 25
- FEI number
- 2650149
In short: On June 13, 2001, FDA issued a Form 483 with 13 observations to Schering-Plough Products, LLC in Manati, Puerto Rico (FEI 2650149) after an inspection that ran May 1 – Jun 13, 2001. The investigators were Carmelo Rosa, Ileana Barreto-Pettit, Ivis L. Negron and Jose F. Pedr. Most observations concern production; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Observations span 1 system, led by production.
Most cited: 21 CFR 211.110 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
sufficient responsibility and authority to exercise the controls reproducible manufacturing processes and controls are established and…
- 02
in addition, you do not have an adequate system fo assure that relevant of submitted to…
- 03
There is insufficient evidence to assure that the current processes used for manufacture of the products…
This inspection in context
Carmelo Rosa
3 documents · 2001–2014
Cites 211.110 (sampling and testing of in-process materials and drug products) 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 211.110
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Schering-Plough Products, LLC?
FDA listed 13 observations on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products). The opening words of each observation are shown on this page.
Who inspected Schering-Plough Products, LLC?
Carmelo Rosa, Ileana Barreto-Pettit, Ivis L. Negron and Jose F. Pedr are named on this Form 483, for the inspection of May 1 – Jun 13, 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 13, 2001, and the Form 483 is dated June 13, 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.