BLA Enterprises, LLC
Form 483 issued December 8, 2016 · Lakewood, Colorado
- Inspection
- Dec 1 – Dec 8, 2016
- Investigator
- Tenzin Jangchup
- Observations
- 12
- Pages
- 4
- FEI number
- 3008763196
In short: On December 8, 2016, FDA issued a Form 483 with 12 observations to BLA Enterprises, LLC in Lakewood, Colorado (FEI 3008763196) after an inspection that ran Dec 1 – Dec 8, 2016. The investigator was Tenzin Jangchup. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.67 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Investigations into deviations from approved processes do not always include a root cause analysis with complete…
- 02
Your firm has failed to establish a program for the qualification of critical raw material suppliers…
- 03
Your cleaning validation is…
- 04
Significant changes to the plant and facilities were not reviewed and approved by the quality…
This inspection in context
Tenzin Jangchup
14 documents · 2015–2019
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Minnesota.
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 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at BLA Enterprises, LLC?
FDA listed 12 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected BLA Enterprises, LLC?
Tenzin Jangchup is named on this Form 483, for the inspection of Dec 1 – Dec 8, 2016. Each investigator has a profile showing what they cite most.
When was BLA Enterprises, LLC inspected by FDA?
The inspection ran Dec 1 – Dec 8, 2016, and the Form 483 is dated December 8, 2016.
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.