Alaunus Pharmaceutical LLC
FDA inspection history in Framingham, Massachusetts, 2012
- 1
- Form 483
Every document, by year
- Form 483
2012: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2012One Form 483, at Framingham, Massachusetts.
Cited most
Across all Alaunus Pharmaceutical observations on file
- 21 CFR 211.166Stability testing1
- 21 CFR 211.186Master production and control records1
- 21 CFR 211.188Batch production and control records1
- 21 CFR 211.94Drug product containers and closures1
The complete Alaunus Pharmaceutical file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Framingham, Massachusetts
One Form 483 · 2012 · 4 observations
Latest: Form 483, Nov 16, 2012 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2012-11-16 | 483 Form 483 | Framingham, Massachusetts | 4 | $99 |
Investigators on these documents
FEI number 3008170448 · most recent document Nov 16, 2012
About Alaunus Pharmaceutical LLC
How many FDA Form 483s has Alaunus Pharmaceutical LLC received?
FDA Intel has 1 Form 483 on file for Alaunus Pharmaceutical LLC; the most recent is dated Nov 16, 2012.
When was Alaunus Pharmaceutical LLC last inspected by FDA?
The most recent FDA inspection document on file for Alaunus Pharmaceutical LLC is a Form 483 dated Nov 16, 2012, for the site in Framingham, Massachusetts.
What did FDA cite at Alaunus Pharmaceutical LLC?
The regulations cited most in the observations on file for Alaunus Pharmaceutical LLC are 21 CFR 211.166 (Stability testing), 1 time; 21 CFR 211.186 (Master production and control records), 1 time; 21 CFR 211.188 (Batch production and control records), 1 time.