Lupin Research Inc
Form 483 issued February 26, 2020 · Coral Springs, Florida
- Observations
- 2
- Pages
- 2
- FEI number
- 3014650220
In short: On February 26, 2020, FDA issued a Form 483 with 2 observations to Lupin Research Inc in Coral Springs, Florida (FEI 3014650220). Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
Production and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.188 (1×) · 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
(Production System) Batch production and control records (BPRs) do not include complete information relating to the…
- 02
(Quality System) The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Questions about this 483
What did FDA find at Lupin Research Inc?
FDA listed 2 observations on this Form 483, mostly about production and quality system. The most-cited regulation is 21 CFR 211.188 (batch production and control records). The opening words of each observation are shown on this page.
When was Lupin Research Inc inspected by FDA?
This Form 483 is dated February 26, 2020.
How do I get the full Form 483 for Lupin Research Inc?
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.