Interquim, S.A.
Form 483 issued September 27, 2019 · Sant Cugat del Valles, Spain
- Inspection
- Sep 23 – Sep 27, 2019
- Investigator
- Jennifer Lalama
- Observations
- 2
- Pages
- 3
- FEI number
- 3002807304
In short: On September 27, 2019, FDA issued a Form 483 with 2 observations to Interquim, S.A. in Sant Cugat del Valles, BA (FEI 3002807304) after an inspection that ran Sep 23 – Sep 27, 2019. The investigator was Jennifer Lalama. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
(b) (4) There is a failure to thoroughly investigate and review any unexplained discrepancy related…
- 02
There is a failure to open deviation documentation (or equivalent) and obtain approval from the quality…
This inspection in context
Jennifer Lalama
31 documents · 2015–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Florida.
The firmInterquim, S.A. history
All 3 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 Interquim, S.A.?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Interquim, S.A.?
Jennifer Lalama is named on this Form 483, for the inspection of Sep 23 – Sep 27, 2019. Each investigator has a profile showing what they cite most.
When was Interquim, S.A. inspected by FDA?
The inspection ran Sep 23 – Sep 27, 2019, and the Form 483 is dated September 27, 2019.
How do I get the full Form 483 for Interquim, S.A.?
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.