Intas Pharmaceuti cal s Li mi ted
Form 483 issued January 24, 2024 · Selaqui, India
- Inspection
- Jan 15 – Jan 24, 2024
- Investigators
- Jeffrey P. Raimondi· Patty P. Kaewussdangkul· Tamil Arasu
- Observations
- 8
- Pages
- 8
- FEI number
- 3005890633
In short: On January 24, 2024, FDA issued a Form 483 with 8 observations to Intas Pharmaceuti cal s Li mi ted in Selaqui, Uttarakhand (FEI 3005890633) after an inspection that ran Jan 15 – Jan 24, 2024. The investigators were Jeffrey P. Raimondi, Patty P. Kaewussdangkul and Tamil Arasu. Most observations concern quality system and facilities & equipment; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Observations span 4 systems, led by quality system.
Most cited: 21 CFR 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into the failure of a batch or any of its components to…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Jeffrey P. Raimondi
40 documents · 2017–2026
Cites 211.42 (design and construction features) more than any other section. Most of their documents are for sites in California.
The firmIntas Pharmaceuti cal s Li mi ted history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.42
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Intas Pharmaceuti cal s Li mi ted?
FDA listed 8 observations on this Form 483, mostly about quality system, facilities & equipment and production. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Intas Pharmaceuti cal s Li mi ted?
Jeffrey P. Raimondi, Patty P. Kaewussdangkul and Tamil Arasu are named on this Form 483, for the inspection of Jan 15 – Jan 24, 2024. Each investigator has a profile showing what they cite most.
When was Intas Pharmaceuti cal s Li mi ted inspected by FDA?
The inspection ran Jan 15 – Jan 24, 2024, and the Form 483 is dated January 24, 2024.
How do I get the full Form 483 for Intas Pharmaceuti cal s Li mi ted?
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.