Torbay Pharmaceuticals Ltd.
Form 483 issued November 12, 2024 · Paignton, United Kingdom
- Inspection
- Nov 4 – Nov 12, 2024
- Observations
- 4
- Pages
- 4
- FEI number
- 3016482316
In short: On November 12, 2024, FDA issued a Form 483 with 4 observations to Torbay Pharmaceuticals Ltd. in Paignton, United Kingdom (FEI 3016482316) after an inspection that ran Nov 4 – Nov 12, 2024. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any…
- 02
Observation 2: scanned text, readable in the full document.
- 03
Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent contamination that would…
- 04
Aseptic processing areas are deficient regarding the system…
This inspection in context
Questions about this 483
What did FDA find at Torbay Pharmaceuticals Ltd.?
FDA listed 4 observations on this Form 483, mostly about quality system and facilities & equipment. The opening words of each observation are shown on this page.
When was Torbay Pharmaceuticals Ltd. inspected by FDA?
The inspection ran Nov 4 – Nov 12, 2024, and the Form 483 is dated November 12, 2024.
How do I get the full Form 483 for Torbay Pharmaceuticals Ltd.?
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.