Wyeth Pharmaceutical, Div Wyeth Holding Corp.
Form 483 issued October 8, 2008 · Pearl River, New York
- Inspection
- Aug 27 – Oct 8, 2008
- Investigator
- J. W. Unknown
- Observations
- 6
- Pages
- 1
- FEI number
- 2410662
In short: On October 8, 2008, FDA issued a Form 483 with 6 observations to Wyeth Pharmaceutical, Div Wyeth Holding Corp. in Pearl River, New York (FEI 2410662) after an inspection that ran Aug 27 – Oct 8, 2008. The investigator was J. W. Unknown. Most observations concern dietary supplement CGMP; the most-cited regulation is 21 CFR 111.320 (what requirements apply to laboratory methods for testing and examination?).
At a glance
5 of 6 observations on this 483 concern dietary supplement cgmp.
Most cited: 21 CFR 111.320 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory exam and test methodologies do not appear to be appropriate…
- 02
Failure to use an appropriate scientifically valid method to test the seal over plastic bottles to…
- 03
Observation 3: scanned text, readable in the full document.
- 04
In the packaging area, failure to demonstrate…
This inspection in context
J. W. Unknown
1 document · 2008
Cites 111.320 (what requirements apply to laboratory methods for testing and examination?) more than any other section. Most of their documents are for sites in New York.
The firmWyeth Pharmaceutical, Div Wyeth Holding Corp. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 111.320
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Wyeth Pharmaceutical, Div Wyeth Holding Corp.?
FDA listed 6 observations on this Form 483, mostly about dietary supplement CGMP. The most-cited regulation is 21 CFR 111.320 (what requirements apply to laboratory methods for testing and examination?). The opening words of each observation are shown on this page.
Who inspected Wyeth Pharmaceutical, Div Wyeth Holding Corp.?
J. W. Unknown is named on this Form 483, for the inspection of Aug 27 – Oct 8, 2008. Each investigator has a profile showing what they cite most.
When was Wyeth Pharmaceutical, Div Wyeth Holding Corp. inspected by FDA?
The inspection ran Aug 27 – Oct 8, 2008, and the Form 483 is dated October 8, 2008.
How do I get the full Form 483 for Wyeth Pharmaceutical, Div Wyeth Holding Corp.?
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.