Baxalta Manufacturing Sàrl
Form 483 issued July 12, 2013 · NEUCHÂTEL, Switzerland
- Inspection
- Jul 4 – Jul 12, 2013
- Investigators
- Jacqueline Diaz-Albertini· Paula A. Trost
- Observations
- 6
- Pages
- 5
- FEI number
- 3002689389
In short: On July 12, 2013, FDA issued a Form 483 with 6 observations to Baxalta Manufacturing Sàrl in NEUCHÂTEL, Switzerland (FEI 3002689389) after an inspection that ran Jul 4 – Jul 12, 2013. The investigators were Jacqueline Diaz-Albertini and Paula A. Trost. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
5 of 6 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (4×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Final Drug Product lots were produced and distributed using produced during a period when the Neuchatel…
- 02
The Advate lyophilized finished product is packaged/labeled with sterile water for injection and a Baxject II…
- 03
Release and Stability testing for the Advate lyophilized final drug product…
- 04
Division Procedures DP(b)(4) "Investigation Out of Specification Test Results" rev. 1, dated April 5, 2002 and…
This inspection in context
Jacqueline Diaz-Albertini
7 documents · 1996–2021
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in New York.
The firmBaxalta Manufacturing Sàrl history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Baxalta Manufacturing Sàrl?
FDA listed 6 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Baxalta Manufacturing Sàrl?
Jacqueline Diaz-Albertini and Paula A. Trost are named on this Form 483, for the inspection of Jul 4 – Jul 12, 2013. Each investigator has a profile showing what they cite most.
When was Baxalta Manufacturing Sàrl inspected by FDA?
The inspection ran Jul 4 – Jul 12, 2013, and the Form 483 is dated July 12, 2013.
How do I get the full Form 483 for Baxalta Manufacturing Sàrl?
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.