Spark Therapeutics, Inc.
FDA inspection history in Philadelphia, Pennsylvania, 2017 to 2022
- 2
- Form 483s
Every document, by year
- Form 483
2017: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017One Form 483, at Philadelphia, Pennsylvania.
- 2022One Form 483, at Philadelphia, Pennsylvania.
- 2022The longest 483 on file: 4 observations over 4 pages at Philadelphia, Pennsylvania.
Cited most
Across all Spark Therapeutics observations on file
- 21 CFR 211.192Production record review3
- 21 CFR 211.100Written procedures; deviations2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.160General requirements1
- 21 CFR 211.25Personnel qualifications1
The complete Spark Therapeutics file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Philadelphia, Pennsylvania
Two Form 483s · 2017 to 2022 · 7 observations
Latest: Form 483, Mar 4, 2022 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-03-04 | 483 Form 483 | Philadelphia, Pennsylvania | 4 | $99 |
| 2017-08-25 | 483 Form 483 | Philadelphia, Pennsylvania | 3 | $99 |
FEI number 3011194531 · most recent document Mar 4, 2022
About Spark Therapeutics, Inc.
How many FDA Form 483s has Spark Therapeutics, Inc. received?
FDA Intel has 2 Form 483s on file for Spark Therapeutics, Inc.; the most recent is dated Mar 4, 2022.
When was Spark Therapeutics, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Spark Therapeutics, Inc. is a Form 483 dated Mar 4, 2022, for the site in Philadelphia, Pennsylvania.
What did FDA cite at Spark Therapeutics, Inc.?
The regulations cited most in the observations on file for Spark Therapeutics, Inc. are 21 CFR 211.192 (Production record review), 3 times; 21 CFR 211.100 (Written procedures; deviations), 2 times; 21 CFR 211.22 (Responsibilities of quality control unit), 2 times.