Orchid Pharma Limited
Form 483 issued February 18, 2025 · Alathur, India
- Inspection
- Feb 10 – Feb 18, 2025
- Investigator
- Rajiv R. Srivastava
- Observations
- 7
- Pages
- 8
- FEI number
- 3003747558
In short: On February 18, 2025, FDA issued a Form 483 with 7 observations to Orchid Pharma Limited in Alathur, India (FEI 3003747558) after an inspection that ran Feb 10 – Feb 18, 2025. The investigator was Rajiv R. Srivastava. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and production account for 5 of 7 observations.
Most cited: 21 CFR 211.67 (2×) · 211.68 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Yom film’s cleaning processes for non-dedicated equipment have not been…
- 02
You have not established the written procedure to ensure that your process can perform effectively and…
- 03
Appropriate qualification of critical equipment and ancillary systems are not completed…
- 04
You failed to test samples of each component for conformity with all appropriate written specifications for…
This inspection in context
Rajiv R. Srivastava
30 documents · 2018–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmOrchid Pharma Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Orchid Pharma Limited?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, production and materials. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Orchid Pharma Limited?
Rajiv R. Srivastava is named on this Form 483, for the inspection of Feb 10 – Feb 18, 2025. Each investigator has a profile showing what they cite most.
When was Orchid Pharma Limited inspected by FDA?
The inspection ran Feb 10 – Feb 18, 2025, and the Form 483 is dated February 18, 2025.
How do I get the full Form 483 for Orchid Pharma 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.