Wyeth Pharmaceutical, Div Wyeth Holding Corp.
Form 483 issued March 17, 2017 · Pearl River, New York
- Inspection
- Mar 9 – Mar 17, 2017
- Investigators
- Antonina Aydanian· Charles Jewell· Diane Raccasi
- Observations
- 7
- Pages
- 4
- FEI number
- 2410662
In short: On March 17, 2017, FDA issued a Form 483 with 7 observations to Wyeth Pharmaceutical, Div Wyeth Holding Corp. in Pearl River, New York (FEI 2410662) after an inspection that ran Mar 9 – Mar 17, 2017. The investigators were Antonina Aydanian, Charles Jewell, Diane Raccasi, Maria J. Lopez-Barragan, Marjorie A. Shapiro, Mate Tolnay and Wayne Seifert. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.67 (2×) · 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be…
- 02
The quality control unit lacks responsibility to approve all procedures or specifications impacting the…
- 03
Equipment and utensils are not maintained at appropriate intervals to prevent malfunctions and contamination that would…
- 04
Laboratory controls did not include scientifically sound and appropriate test procedures designed to assure that components…
This inspection in context
Antonina Aydanian
1 document · 2017
Cites 211.160 (general requirements) 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 211.67
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 7 observations on this Form 483, mostly about production, facilities & equipment and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Wyeth Pharmaceutical, Div Wyeth Holding Corp.?
Antonina Aydanian, Charles Jewell, Diane Raccasi, Maria J. Lopez-Barragan, Marjorie A. Shapiro, Mate Tolnay and Wayne Seifert are named on this Form 483, for the inspection of Mar 9 – Mar 17, 2017. Each investigator has a profile showing what they cite most.
When was Wyeth Pharmaceutical, Div Wyeth Holding Corp. inspected by FDA?
The inspection ran Mar 9 – Mar 17, 2017, and the Form 483 is dated March 17, 2017.
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.