Spark Therapeutics, Inc.
Form 483 issued August 25, 2017 · Philadelphia, Pennsylvania
- Inspection
- Aug 21 – Aug 25, 2017
- Observations
- 3
- Pages
- 3
- FEI number
- 3011194531
In short: On August 25, 2017, FDA issued a Form 483 with 3 observations to Spark Therapeutics, Inc. in Philadelphia, Pennsylvania (FEI 3011194531) after an inspection that ran Aug 21 – Aug 25, 2017. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
3 of 3 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (2×) · 211.25 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Deviations/Investigations (DIs) were not extended and/or reviewed, and closed out in a timely manner as per…
- 02
Corrective actions were not consistently established for recurring deviations…
- 03
Regarding the Training Program…
This inspection in context
Questions about this 483
What did FDA find at Spark Therapeutics, Inc.?
FDA listed 3 observations on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was Spark Therapeutics, Inc. inspected by FDA?
The inspection ran Aug 21 – Aug 25, 2017, and the Form 483 is dated August 25, 2017.
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.