Alchem International Private Ltd.
Form 483 issued July 22, 2024 · Alwar, India
- Inspection
- Jul 15 – Jul 22, 2024
- Investigator
- Kellia N. Hicks
- Observations
- 2
- Pages
- 2
- FEI number
- 3009344588
In short: On July 22, 2024, FDA issued a Form 483 with 2 observations to Alchem International Private Ltd. in Alwar, Rajasthan (FEI 3009344588) after an inspection that ran Jul 15 – Jul 22, 2024. The investigator was Kellia N. Hicks. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Laboratory controls and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.160 (1×) · 211.192 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Failure to establish and implement procedures for method verification of USP test methods used for…
- 02
Failure to investigate critical deviations and implement corrective actions in…
This inspection in context
Kellia N. Hicks
28 documents · 2017–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmAlchem International Private Ltd. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Alchem International Private Ltd.?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and 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.
Who inspected Alchem International Private Ltd.?
Kellia N. Hicks is named on this Form 483, for the inspection of Jul 15 – Jul 22, 2024. Each investigator has a profile showing what they cite most.
When was Alchem International Private Ltd. inspected by FDA?
The inspection ran Jul 15 – Jul 22, 2024, and the Form 483 is dated July 22, 2024.
How do I get the full Form 483 for Alchem International Private Ltd.?
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