Llorens Pharmaceuticals International
FDA inspection history in Miami, Florida, 2019 to 2020
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2020: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–20Two Form 483s, at Miami, Florida.
- 2020The longest 483 on file: 4 observations over 4 pages at Miami, Florida.
Cited most
Across all Llorens Pharmaceuticals International observations on file
- 21 CFR 211.22(b)Responsibilities of quality control unit2
- 21 CFR 111.255(d)What is the requirement to establish a batch production record?1
- 21 CFR 211.188(b)(5)Batch production and control records1
- 21 CFR 211.194(a)(2)Laboratory records1
The complete Llorens Pharmaceuticals International 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
Miami, Florida
Two Form 483s · 2019 to 2020 · 5 observations
Latest: Form 483, Mar 11, 2020 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-03-11 | 483 Form 483 | Miami, Florida | 4 | $99 |
| 2019-08-29 | 483 Form 483 | Miami, Florida | 1 | $99 |
Investigators on these documents
FEI number 3008468946 · most recent document Mar 11, 2020
About Llorens Pharmaceuticals International
How many FDA Form 483s has Llorens Pharmaceuticals International received?
FDA Intel has 2 Form 483s on file for Llorens Pharmaceuticals International; the most recent is dated Mar 11, 2020.
When was Llorens Pharmaceuticals International last inspected by FDA?
The most recent FDA inspection document on file for Llorens Pharmaceuticals International is a Form 483 dated Mar 11, 2020, for the site in Miami, Florida.
What did FDA cite at Llorens Pharmaceuticals International?
The regulations cited most in the observations on file for Llorens Pharmaceuticals International are 21 CFR 211.22(b) (Responsibilities of quality control unit), 2 times; 21 CFR 111.255(d) (What is the requirement to establish a batch production record?), 1 time; 21 CFR 211.188(b)(5) (Batch production and control records), 1 time.