Ensign Laboratories Proprietary Limited
Form 483 issued July 15, 2022 · Mulgrave, Australia
- Inspection
- Jul 11 – Jul 15, 2022
- Investigator
- Erik W. Koester
- Observations
- 5
- Pages
- 5
- FEI number
- 3003380641
In short: On July 15, 2022, FDA issued a Form 483 with 5 observations to Ensign Laboratories Proprietary Limited in Mulgrave, Victoria (FEI 3003380641) after an inspection that ran Jul 11 – Jul 15, 2022. The investigator was Erik W. Koester. Most observations concern facilities & equipment and production.
At a glance
Facilities & equipment and production account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
There are no written procedures for production and process controls designed to assure that the drug…
- 02
Routine calibration of mechanical equipment is not performed according to a written program designed…
- 03
The establishment of test procedures including any changes thereto, are not reviewed and approved by…
- 04
Equipment and utensils are not cleaned at appropriate intervals to prevent contamination that would alter the…
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 firmEnsign Laboratories Proprietary Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ensign Laboratories Proprietary Limited?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Ensign Laboratories Proprietary Limited?
Erik W. Koester is named on this Form 483, for the inspection of Jul 11 – Jul 15, 2022. Each investigator has a profile showing what they cite most.
When was Ensign Laboratories Proprietary Limited inspected by FDA?
The inspection ran Jul 11 – Jul 15, 2022, and the Form 483 is dated July 15, 2022.
How do I get the full Form 483 for Ensign Laboratories Proprietary Limited?
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.