Zydus Group
Form 483 issued December 22, 2023 · Ahmedabad, India
- Observations
- 6
- Pages
- 6
- FEI number
- 3006595385
In short: On December 22, 2023, FDA issued a Form 483 with 6 observations to Zydus Group in Ahmedabad, Gujarat (FEI 3006595385). Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and production account for 5 of 6 observations.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Documented evidence that a process can produce intermediate meeting its…
- 02
Investigations of unexpected occurrences or the failure of a batch to meet specifications are not adequately…
- 03
Test methods used are not…
- 04
The change control system does not adequately assess that impact of changes that may affect the…
This inspection in context
Questions about this 483
What did FDA find at Zydus Group?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, production and quality system. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was Zydus Group inspected by FDA?
This Form 483 is dated December 22, 2023.
How do I get the full Form 483 for Zydus Group?
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.