Biotika A.S. Slovenska Lupca 566
Form 483 issued June 1, 2018 · Slovenska Lupca, Slovakia
- Inspection
- May 28 – Jun 1, 2018
- Observations
- 1
- Pages
- 3
- FEI number
- 3003370212
In short: On June 1, 2018, FDA issued a Form 483 with 1 observation to Biotika A.S. Slovenska Lupca 566 in Slovenska Lupca, Slovakia (FEI 3003370212) after an inspection that ran May 28 – Jun 1, 2018. Most observations concern production; the most-cited regulation is 21 CFR 211.188 (batch production and control records).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.188 (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) Completion of significant steps in batch production and control…
This inspection in context
Questions about this 483
What did FDA find at Biotika A.S. Slovenska Lupca 566?
FDA listed 1 observation on this Form 483, mostly about production. 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 Biotika A.S. Slovenska Lupca 566 inspected by FDA?
The inspection ran May 28 – Jun 1, 2018, and the Form 483 is dated June 1, 2018.
How do I get the full Form 483 for Biotika A.S. Slovenska Lupca 566?
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.