Indoco Remedies Limited
Form 483 issued November 21, 2018 · Verna, India
- Inspection
- Nov 14 – Nov 21, 2018
- Observations
- 2
- Pages
- 10
- FEI number
- 3005124189
In short: On November 21, 2018, FDA issued a Form 483 with 2 observations to Indoco Remedies Limited in Verna, Goa (FEI 3005124189) after an inspection that ran Nov 14 – Nov 21, 2018. Most observations concern quality system; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
2 of 2 observations on this 483 concern quality system.
Most cited: 21 CFR 211.198(a) (1×) · 211.22(d) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures describing the handling of written and oral complaints related to drug products are…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Questions about this 483
What did FDA find at Indoco Remedies Limited?
FDA listed 2 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.
When was Indoco Remedies Limited inspected by FDA?
The inspection ran Nov 14 – Nov 21, 2018, and the Form 483 is dated November 21, 2018.
How do I get the full Form 483 for Indoco Remedies 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.