Baxter Laboratories Pty. Ltd.
Form 483 issued July 22, 2022 · Boronia, Australia
- Investigator
- Erik W. Koester
- Observations
- 5
- Pages
- 4
- FEI number
- 3003945201
In short: On July 22, 2022, FDA issued a Form 483 with 5 observations to Baxter Laboratories Pty. Ltd. in Boronia, Victoria (FEI 3003945201). The investigator was Erik W. Koester. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
3 of 5 observations on this 483 concern facilities & equipment.
What FDA observed
Preview: the opening words of each observation- 01
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 02
Routine calibration of mechanical equipment is not performed according to a written program designed…
- 03
Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Erik W. Koester
40 documents · 2006–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in Massachusetts.
The firmBaxter Laboratories Pty. Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Baxter Laboratories Pty. Ltd.?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Baxter Laboratories Pty. Ltd.?
Erik W. Koester is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Baxter Laboratories Pty. Ltd. inspected by FDA?
This Form 483 is dated July 22, 2022.
How do I get the full Form 483 for Baxter Laboratories Pty. Ltd.?
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.