Smilax Laboratories Limited
Form 483 issued September 15, 2023 · Visakhapatnam, India
- Observations
- 1
- Pages
- 1
- FEI number
- 3008772334
In short: On September 15, 2023, FDA issued a Form 483 with 1 observation to Smilax Laboratories Limited in Visakhapatnam, Andhra Pradesh (FEI 3008772334). Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×) · 211.198 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
This inspection in context
Questions about this 483
What did FDA find at Smilax Laboratories Limited?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was Smilax Laboratories Limited inspected by FDA?
This Form 483 is dated September 15, 2023.
How do I get the full Form 483 for Smilax Laboratories Limited?
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.