Medispray Laboratories Private Limited
Form 483 issued January 20, 2025 · Ponda, India
- Inspection
- Jan 14 – Jan 20, 2025
- Investigator
- Guerlain Ulysse
- Observations
- 1
- Pages
- 2
- FEI number
- 3004881451
In short: On January 20, 2025, FDA issued a Form 483 with 1 observation to Medispray Laboratories Private Limited in Ponda, Goa (FEI 3004881451) after an inspection that ran Jan 14 – Jan 20, 2025. The investigator was Guerlain Ulysse. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit are not in…
This inspection in context
Guerlain Ulysse
32 documents · 2016–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmMedispray Laboratories Private Limited history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medispray Laboratories Private Limited?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Medispray Laboratories Private Limited?
Guerlain Ulysse is named on this Form 483, for the inspection of Jan 14 – Jan 20, 2025. Each investigator has a profile showing what they cite most.
When was Medispray Laboratories Private Limited inspected by FDA?
The inspection ran Jan 14 – Jan 20, 2025, and the Form 483 is dated January 20, 2025.
How do I get the full Form 483 for Medispray Laboratories Private 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.