Form 483 · FEI 3009864467
Form 483 issued June 13, 2023 · Stirling, United Kingdom
- Inspection
- Jun 5 – Jun 13, 2023
- Investigator
- Pratik S. Upadhyay
- Observations
- 1
- Pages
- 9
- FEI number
- 3009864467
In short: On June 13, 2023, FDA issued a Form 483 with 1 observation to an FDA-inspected site in Stirling, United Kingdom (FEI 3009864467) after an inspection that ran Jun 5 – Jun 13, 2023. The investigator was Pratik S. Upadhyay. Most observations concern production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
1 of 1 observations on this 483 concern production.
Most cited: 21 CFR 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include…
This inspection in context
Pratik S. Upadhyay
48 documents · 2011–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmSite history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at an FDA-inspected site?
FDA listed 1 observation on this Form 483, mostly about production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected an FDA-inspected site?
Pratik S. Upadhyay is named on this Form 483, for the inspection of Jun 5 – Jun 13, 2023. Each investigator has a profile showing what they cite most.
When was an FDA-inspected site inspected by FDA?
The inspection ran Jun 5 – Jun 13, 2023, and the Form 483 is dated June 13, 2023.
How do I get the full Form 483 for an FDA-inspected site?
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.