Ensign Laboratories Proprietary Limited
FDA inspection history in Mulgrave, Australia, 2022
- 1
- Form 483
Every document, by year
- Form 483
2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022One Form 483, at Mulgrave, Australia.
Cited most
Across all Ensign Laboratories Proprietary Limited observations on file
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.160(a)General requirements1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
- 21 CFR 211.67(a)Equipment cleaning and maintenance1
- 21 CFR 211.68(a)Automatic, mechanical, and electronic equipment1
The complete Ensign Laboratories Proprietary Limited file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Mulgrave, Australia
One Form 483 · 2022 · 5 observations
Latest: Form 483, Jul 15, 2022 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-07-15 | 483 Form 483 | Mulgrave, Australia | 5 | $99 |
Investigators on these documents
FEI number 3003380641 · most recent document Jul 15, 2022
About Ensign Laboratories Proprietary Limited
How many FDA Form 483s has Ensign Laboratories Proprietary Limited received?
FDA Intel has 1 Form 483 on file for Ensign Laboratories Proprietary Limited; the most recent is dated Jul 15, 2022.
When was Ensign Laboratories Proprietary Limited last inspected by FDA?
The most recent FDA inspection document on file for Ensign Laboratories Proprietary Limited is a Form 483 dated Jul 15, 2022, for the site in Mulgrave, Australia.
What did FDA cite at Ensign Laboratories Proprietary Limited?
The regulations cited most in the observations on file for Ensign Laboratories Proprietary Limited are 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.160(a) (General requirements), 1 time; 21 CFR 211.22(d) (Responsibilities of quality control unit), 1 time.