Apertus Pharmaceuticals, LLC
FDA inspection history in Ballwin, Missouri, 2020
- 1
- Form 483
Every document, by year
- Form 483
2020: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2020One Form 483, at Ballwin, Missouri.
Cited most
Across all Apertus Pharmaceuticals observations on file
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.130Packaging and labeling operations1
- 21 CFR 211.180General requirements1
The complete Apertus Pharmaceuticals file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Ballwin, Missouri
One Form 483 · 2020 · 5 observations
Latest: Form 483, Jan 16, 2020 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-01-16 | 483 Form 483 | Ballwin, Missouri | 5 | $99 |
Investigators on these documents
Ana P. Sandee (1)Michele Perry Williams (1)Robert J. Ham (1)
FEI number 3010401502 · most recent document Jan 16, 2020
About Apertus Pharmaceuticals, LLC
How many FDA Form 483s has Apertus Pharmaceuticals, LLC received?
FDA Intel has 1 Form 483 on file for Apertus Pharmaceuticals, LLC; the most recent is dated Jan 16, 2020.
When was Apertus Pharmaceuticals, LLC last inspected by FDA?
The most recent FDA inspection document on file for Apertus Pharmaceuticals, LLC is a Form 483 dated Jan 16, 2020, for the site in Ballwin, Missouri.
What did FDA cite at Apertus Pharmaceuticals, LLC?
The regulations cited most in the observations on file for Apertus Pharmaceuticals, LLC are 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 2 times; 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.130 (Packaging and labeling operations), 1 time.