SERUM INSTITUTE OF INDIA PRIVATE LIMITED
Form 483 issued July 2, 2024 · Pune, India
- Inspection
- Jun 29 – Jul 2, 2024
- Investigators
- Anissa M. Cheung· Latorie S. Jones
- Observations
- 5
- Pages
- 3
- FEI number
- 3020223359
In short: On July 2, 2024, FDA issued a Form 483 with 5 observations to SERUM INSTITUTE OF INDIA PRIVATE LIMITED in Pune, Maharashtra (FEI 3020223359) after an inspection that ran Jun 29 – Jul 2, 2024. The investigators were Anissa M. Cheung and Latorie S. Jones. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Production and facilities & equipment account for 3 of 5 observations.
Most cited: 21 CFR 211.192 (2×)
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.
- 02
Observation 2: scanned text, readable in the full document.
- 03
Observation 3: scanned text, readable in the full document.
- 04
There is a lack of (6) (4) data in the qualification report for (©) reference standard…
This inspection in context
Anissa M. Cheung
7 documents · 2017–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Massachusetts.
The firmSERUM INSTITUTE OF INDIA PRIVATE 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 SERUM INSTITUTE OF INDIA PRIVATE LIMITED?
FDA listed 5 observations on this Form 483, mostly about production, facilities & equipment 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 SERUM INSTITUTE OF INDIA PRIVATE LIMITED?
Anissa M. Cheung and Latorie S. Jones are named on this Form 483, for the inspection of Jun 29 – Jul 2, 2024. Each investigator has a profile showing what they cite most.
When was SERUM INSTITUTE OF INDIA PRIVATE LIMITED inspected by FDA?
The inspection ran Jun 29 – Jul 2, 2024, and the Form 483 is dated July 2, 2024.
How do I get the full Form 483 for SERUM INSTITUTE OF INDIA PRIVATE LIMITED?
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