Diasol East, Inc.
FDA inspection history across 2 sites, 2017 to 2018
- 2
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2017: one warning letter and one Form 483; 2018: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–18Two Form 483s and one warning letter, at San Fernando, California and Watertown, Tennessee.
- 2018The longest 483 on file: 12 observations over 18 pages at Watertown, Tennessee.
Cited most
Across all Diasol East observations on file
- 21 CFR 820.70(a)Production and process controls3
- 21 CFR 820.90(a)Nonconforming product2
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.120Device labeling1
- 21 CFR 820.22Quality audit1
The complete Diasol East 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
Watertown, Tennessee
Two Form 483s · 2017 to 2018 · 13 observations
Latest: Form 483, Aug 22, 2018 →San Fernando, California
One warning letter · 2017
Latest: Warning letter, Jul 12, 2017 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-08-22 | 483 Form 483 | Watertown, Tennessee | 12 | $99 |
| 2017-07-12 | Warning letter Warning letter | San Fernando, California | — | $99 |
| 2017-03-17 | 483 Form 483 | Watertown, Tennessee | 1 | $99 |
Investigators on these documents
FEI number 3012248013 · most recent document Aug 22, 2018
About Diasol East, Inc.
How many FDA Form 483s has Diasol East, Inc. received?
FDA Intel has 2 Form 483s on file for Diasol East, Inc.; the most recent is dated Aug 22, 2018.
When was Diasol East, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Diasol East, Inc. is a Form 483 dated Aug 22, 2018, for the site in Watertown, Tennessee.
What did FDA cite at Diasol East, Inc.?
The regulations cited most in the observations on file for Diasol East, Inc. are 21 CFR 820.70(a) (Production and process controls), 3 times; 21 CFR 820.90(a) (Nonconforming product), 2 times; 21 CFR 820.100(a) (Corrective and preventive action), 1 time.
Has Diasol East, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Diasol East, Inc.; the most recent is dated Jul 12, 2017.