Zydus Animal Health and Investments Limited
Form 483 issued September 29, 2022 · AHMEDABAD, India
- Investigator
- Michael A. Charles
- Observations
- 2
- Pages
- 3
- FEI number
- 3015849306
In short: On September 29, 2022, FDA issued a Form 483 with 2 observations to Zydus Animal Health and Investments Limited in AHMEDABAD, Gujarat (FEI 3015849306). The investigator was Michael A. Charles. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and laboratory controls account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Unexplained discrepancies are not always…
- 02
The (b) (4)manufacturing system does not have fully meaningful sampling plan and is…
This inspection in context
Michael A. Charles
29 documents · 2013–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Colorado.
The firmZydus Animal Health and Investments Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Zydus Animal Health and Investments Limited?
FDA listed 2 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Zydus Animal Health and Investments Limited?
Michael A. Charles is named on this Form 483. Each investigator has a profile showing what they cite most.
When was Zydus Animal Health and Investments Limited inspected by FDA?
This Form 483 is dated September 29, 2022.
How do I get the full Form 483 for Zydus Animal Health and Investments 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.