FDA Form 483 Roslin Cell Therapies Limited January 2025
Form 483 issued January 21, 2025
- Inspection
- Jan 13 – Jan 21, 2025
- Observations
- 3
- Pages
- 4
In short: On January 21, 2025, FDA issued a Form 483 with 3 observations to FDA Form 483 Roslin Cell Therapies Limited January 2025 after an inspection that ran Jan 13 – Jan 21, 2025. Most observations concern production and facilities & equipment; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Production and facilities & equipment account for 2 of 3 observations.
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…
- 02
Appropriate controls are not exercised over "'"' or related systems to assure that changes in master…
- 03
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Questions about this 483
What did FDA find at FDA Form 483 Roslin Cell Therapies Limited January 2025?
FDA listed 3 observations on this Form 483, mostly about production, facilities & equipment and 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.
When was FDA Form 483 Roslin Cell Therapies Limited January 2025 inspected by FDA?
The inspection ran Jan 13 – Jan 21, 2025, and the Form 483 is dated January 21, 2025.
How do I get the full Form 483 for FDA Form 483 Roslin Cell Therapies Limited January 2025?
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.