Spark Therapeutics, Inc.
Form 483 issued March 4, 2022 · Philadelphia, Pennsylvania
- Inspection
- Feb 28 – Mar 4, 2022
- Observations
- 4
- Pages
- 4
- FEI number
- 3011194531
In short: On March 4, 2022, FDA issued a Form 483 with 4 observations to Spark Therapeutics, Inc. in Philadelphia, Pennsylvania (FEI 3011194531) after an inspection that ran Feb 28 – Mar 4, 2022. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Production and laboratory controls account for 3 of 4 observations.
Most cited: 21 CFR 211.100 (2×) · 211.22 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Observation 1: scanned text, readable in the full document.
- 02
Observation 2: scanned text, readable in the full document.
- 03
Observation 3: scanned text, readable in the full document.
- 04
There is lack of Quality oversight by Spark Therapeutics, the license holder, for all service providers…
This inspection in context
Questions about this 483
What did FDA find at Spark Therapeutics, Inc.?
FDA listed 4 observations on this Form 483, mostly about production, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
When was Spark Therapeutics, Inc. inspected by FDA?
The inspection ran Feb 28 – Mar 4, 2022, and the Form 483 is dated March 4, 2022.
How do I get the full Form 483 for Spark Therapeutics, Inc.?
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.