BLA Enterprises, LLC
Form 483 issued December 13, 2021 · Lakewood, Colorado
- Inspection
- Dec 3 – Dec 13, 2021
- Investigator
- Alan P. Kurtzberg
- Observations
- 5
- Pages
- 4
- FEI number
- 3008763196
In short: On December 13, 2021, FDA issued a Form 483 with 5 observations to BLA Enterprises, LLC in Lakewood, Colorado (FEI 3008763196) after an inspection that ran Dec 3 – Dec 13, 2021. The investigator was Alan P. Kurtzberg. Most observations concern quality system and production.
At a glance
Quality system and production account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 02
The responsibilities and procedures applicable to the quality control unit…
- 03
There are no written procedures for production and process controls designed to assure that the drug…
- 04
The master production and control records for each batch size of drug product are not prepared…
This inspection in context
Alan P. Kurtzberg
24 documents · 2015–2023
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
The firmBLA Enterprises, LLC history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BLA Enterprises, LLC?
FDA listed 5 observations on this Form 483, mostly about quality system, production and packaging & labeling. The opening words of each observation are shown on this page.
Who inspected BLA Enterprises, LLC?
Alan P. Kurtzberg is named on this Form 483, for the inspection of Dec 3 – Dec 13, 2021. Each investigator has a profile showing what they cite most.
When was BLA Enterprises, LLC inspected by FDA?
The inspection ran Dec 3 – Dec 13, 2021, and the Form 483 is dated December 13, 2021.
How do I get the full Form 483 for BLA Enterprises, LLC?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.