Grindeks JSC
Form 483 issued August 24, 2018 · Riga, Latvia
- Inspection
- Aug 22 – Aug 24, 2018
- Observations
- 8
- Pages
- 6
- FEI number
- 3001597955
In short: On August 24, 2018, FDA issued a Form 483 with 8 observations to Grindeks JSC in Riga, Latvia (FEI 3001597955) after an inspection that ran Aug 22 – Aug 24, 2018. Most observations concern facilities & equipment and laboratory controls; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
Facilities & equipment and laboratory controls account for 6 of 8 observations.
Most cited: 21 CFR 211.68 (2×) · 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
Controls over electronic laboratory data to ensure the API’s identity, strength, quality and purity…
- 02
Laboratory control records do not include complete data derived from all tests conducted to ensure compliance…
- 03
Raw materials sampling plan and procedures are not appropriate to ensure uniform samples of key starting…
- 04
Each batch of intermediate and API should be tested to determine conformance to specifications submitted…
This inspection in context
Questions about this 483
What did FDA find at Grindeks JSC?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, laboratory controls and materials. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
When was Grindeks JSC inspected by FDA?
The inspection ran Aug 22 – Aug 24, 2018, and the Form 483 is dated August 24, 2018.
How do I get the full Form 483 for Grindeks JSC?
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.