Analytical Control Systems, Inc
FDA inspection history in Fishers, Indiana, 2014 to 2019
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2014: one warning letter; 2016: one Form 483; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–16One warning letter and one Form 483, at Fishers, Indiana.
- 2016The longest 483 on file: 6 observations over 4 pages at Fishers, Indiana.
- 2019One Form 483, at Fishers, Indiana.
Cited most
Across all Analytical Control Systems observations on file
- 21 CFR 820.20(c)Management responsibility2
- 21 CFR 820.22Quality audit2
- 21 CFR 820.75(a)Process validation2
- 21 CFR 820.130Device packaging1
- 21 CFR 820.181Device master record1
The complete Analytical Control Systems file.
All 3 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
Fishers, Indiana
Two Form 483s and one warning letter · 2014 to 2019 · 10 observations
Latest: Form 483, Dec 19, 2019 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-12-19 | 483 Form 483 | Fishers, Indiana | 4 | $99 |
| 2016-02-29 | 483 Form 483 | Fishers, Indiana | 6 | $99 |
| 2014-05-08 | Warning letter Warning letter | Fishers, Indiana | — | $99 |
Investigators on these documents
FEI number 1825740 · most recent document Dec 19, 2019
About Analytical Control Systems, Inc
How many FDA Form 483s has Analytical Control Systems, Inc received?
FDA Intel has 2 Form 483s on file for Analytical Control Systems, Inc; the most recent is dated Dec 19, 2019.
When was Analytical Control Systems, Inc last inspected by FDA?
The most recent FDA inspection document on file for Analytical Control Systems, Inc is a Form 483 dated Dec 19, 2019, for the site in Fishers, Indiana.
What did FDA cite at Analytical Control Systems, Inc?
The regulations cited most in the observations on file for Analytical Control Systems, Inc are 21 CFR 820.20(c) (Management responsibility), 2 times; 21 CFR 820.22 (Quality audit), 2 times; 21 CFR 820.75(a) (Process validation), 2 times.
Has Analytical Control Systems, Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Analytical Control Systems, Inc; the most recent is dated May 8, 2014.