Sandoz, Inc.
Form 483 issued June 22, 2011 · Wilson, North Carolina
- Inspection
- Jun 6 – Jun 22, 2011
- Investigators
- Hai Lien T. Phung· Luis M. Burgos Medero· Tonshina R. Hall
- Observations
- 8
- Pages
- 11
- FEI number
- 3000210731
In short: On June 22, 2011, FDA issued a Form 483 with 8 observations to Sandoz, Inc. in Wilson, North Carolina (FEI 3000210731) after an inspection that ran Jun 6 – Jun 22, 2011. The investigators were Hai Lien T. Phung, Luis M. Burgos Medero and Tonshina R. Hall. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.110 (sampling and testing of in-process materials and drug products).
At a glance
Production and laboratory controls account for 5 of 7 observations.
Most cited: 21 CFR 211.110 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit…
- 02
There are no written procedures for production and process controls designed to assure that the drug…
- 03
Control procedures are not established which validate the performance of those manufacturing processes that may be…
- 04
Examination and testing of samples is not done to assure that in-process…
This inspection in context
Hai Lien T. Phung
1 document · 2011
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 North Carolina.
The firmSandoz, Inc. history
All 2 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 Sandoz, Inc.?
FDA listed 8 observations on this Form 483, mostly about production, laboratory controls and quality system. 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 Sandoz, Inc.?
Hai Lien T. Phung, Luis M. Burgos Medero and Tonshina R. Hall are named on this Form 483, for the inspection of Jun 6 – Jun 22, 2011. Each investigator has a profile showing what they cite most.
When was Sandoz, Inc. inspected by FDA?
The inspection ran Jun 6 – Jun 22, 2011, and the Form 483 is dated June 22, 2011.
How do I get the full Form 483 for Sandoz, Inc.?
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.