Asept Pak Inc
FDA inspection history in Malone, New York, 2016 to 2019
- 2
- Form 483s
Every document, by year
- Form 483
2016: one Form 483; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483, at Malone, New York.
- 2019One Form 483, at Malone, New York.
- 2019The longest 483 on file: 7 observations over 7 pages at Malone, New York.
Cited most
Across all Asept Pak observations on file
- 21 CFR 211.137(a)Expiration dating2
- 21 CFR 820.70(c)Production and process controls2
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.113(b)Control of microbiological contamination1
- 21 CFR 211.180(e)General requirements1
The complete Asept Pak file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Malone, New York
Two Form 483s · 2016 to 2019 · 11 observations
Latest: Form 483, Dec 20, 2019 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-12-20 | 483 Form 483 | Malone, New York | 7 | $99 |
| 2016-04-21 | 483 Form 483 | Malone, New York | 4 | $99 |
Investigators on these documents
FEI number 3007177643 · most recent document Dec 20, 2019
About Asept Pak Inc
How many FDA Form 483s has Asept Pak Inc received?
FDA Intel has 2 Form 483s on file for Asept Pak Inc; the most recent is dated Dec 20, 2019.
When was Asept Pak Inc last inspected by FDA?
The most recent FDA inspection document on file for Asept Pak Inc is a Form 483 dated Dec 20, 2019, for the site in Malone, New York.
What did FDA cite at Asept Pak Inc?
The regulations cited most in the observations on file for Asept Pak Inc are 21 CFR 211.137(a) (Expiration dating), 2 times; 21 CFR 820.70(c) (Production and process controls), 2 times; 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 1 time.