Destileria Serralles, Inc
FDA inspection history in Mercedita, Puerto Rico, 2016 to 2021
- 2
- Form 483s
Every document, by year
- Form 483
2016: one Form 483; 2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483, at Mercedita, Puerto Rico.
- 2016The longest 483 on file: 12 observations over 9 pages at Mercedita, Puerto Rico.
- 2021One Form 483, at Mercedita, Puerto Rico.
Cited most
Across all Destileria Serralles observations on file
- 21 CFR 211.22(a)Responsibilities of quality control unit5
- 21 CFR 211.84(b)Testing and approval or rejection of components, drug product containers, and closures5
- 21 CFR 211.137(a)Expiration dating2
- 21 CFR 211.165(a)Testing and release for distribution2
- 21 CFR 211.67(a)Equipment cleaning and maintenance2
The complete Destileria Serralles 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
Mercedita, Puerto Rico
Two Form 483s · 2016 to 2021 · 21 observations
Latest: Form 483, Mar 11, 2021 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-03-11 | 483 Form 483 | Mercedita, Puerto Rico | 9 | $99 |
| 2016-08-09 | 483 Form 483 | Mercedita, Puerto Rico | 12 | $99 |
Investigators on these documents
FEI number 3009888617 · most recent document Mar 11, 2021
About Destileria Serralles, Inc
How many FDA Form 483s has Destileria Serralles, Inc received?
FDA Intel has 2 Form 483s on file for Destileria Serralles, Inc; the most recent is dated Mar 11, 2021.
When was Destileria Serralles, Inc last inspected by FDA?
The most recent FDA inspection document on file for Destileria Serralles, Inc is a Form 483 dated Mar 11, 2021, for the site in Mercedita, Puerto Rico.
What did FDA cite at Destileria Serralles, Inc?
The regulations cited most in the observations on file for Destileria Serralles, Inc are 21 CFR 211.22(a) (Responsibilities of quality control unit), 5 times; 21 CFR 211.84(b) (Testing and approval or rejection of components, drug product containers, and closures), 5 times; 21 CFR 211.137(a) (Expiration dating), 2 times.