BLA Enterprises, LLC
FDA inspection history in Lakewood, Colorado, 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 Lakewood, Colorado.
- 2016The longest 483 on file: 12 observations over 4 pages at Lakewood, Colorado.
- 2021One Form 483, at Lakewood, Colorado.
Cited most
Across all BLA Enterprises observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 111.113What quality control operations are required for a material review and disposition decision?1
- 21 CFR 111.560What requirements apply to the review and investigation of a product complaint?1
The complete BLA Enterprises 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
Lakewood, Colorado
Two Form 483s · 2016 to 2021 · 17 observations
Latest: Form 483, Dec 13, 2021 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-12-13 | 483 Form 483 | Lakewood, Colorado | 5 | $99 |
| 2016-12-08 | 483 Form 483 | Lakewood, Colorado | 12 | $99 |
Investigators on these documents
FEI number 3008763196 · most recent document Dec 13, 2021
About BLA Enterprises, LLC
How many FDA Form 483s has BLA Enterprises, LLC received?
FDA Intel has 2 Form 483s on file for BLA Enterprises, LLC; the most recent is dated Dec 13, 2021.
When was BLA Enterprises, LLC last inspected by FDA?
The most recent FDA inspection document on file for BLA Enterprises, LLC is a Form 483 dated Dec 13, 2021, for the site in Lakewood, Colorado.
What did FDA cite at BLA Enterprises, LLC?
The regulations cited most in the observations on file for BLA Enterprises, LLC are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.22 (Responsibilities of quality control unit), 2 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times.