PerkinElmer Health Sciences, Inc
FDA inspection history in Waltham, Massachusetts, 2014 to 2019
- 1
- Form 483
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Form 483
- Close-out
- Warning letter
2014: one warning letter; 2017: one close-out letter; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014One warning letter, at Waltham, Massachusetts.
- 2017–19One close-out letter and one Form 483, at Waltham, Massachusetts.
Cited most
Across all PerkinElmer Health Sciences observations on file
- 21 CFR 820.70Production and process controls2
- 21 CFR 8201
- 21 CFR 807.81When a premarket notification submission is required1
The complete PerkinElmer Health Sciences file.
All 3 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
Waltham, Massachusetts
One Form 483, one close-out letter and one warning letter · 2014 to 2019 · 4 observations
Latest: Form 483, Aug 1, 2019 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-08-01 | 483 Form 483 | Waltham, Massachusetts | 4 | $99 |
| 2017-01-13 | Close-out Close-out letter | Waltham, Massachusetts | — | $99 |
| 2014-10-23 | Warning letter Warning letter | Waltham, Massachusetts | — | $99 |
Investigators on these documents
FEI number 3006159931 · most recent document Aug 1, 2019
About PerkinElmer Health Sciences, Inc
How many FDA Form 483s has PerkinElmer Health Sciences, Inc received?
FDA Intel has 1 Form 483 on file for PerkinElmer Health Sciences, Inc; the most recent is dated Aug 1, 2019.
When was PerkinElmer Health Sciences, Inc last inspected by FDA?
The most recent FDA inspection document on file for PerkinElmer Health Sciences, Inc is a Form 483 dated Aug 1, 2019, for the site in Waltham, Massachusetts.
What did FDA cite at PerkinElmer Health Sciences, Inc?
The regulations cited most in the observations on file for PerkinElmer Health Sciences, Inc are 21 CFR 820.70 (Production and process controls), 2 times; 21 CFR 820, 1 time; 21 CFR 807.81 (When a premarket notification submission is required), 1 time.
Has PerkinElmer Health Sciences, Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for PerkinElmer Health Sciences, Inc; the most recent is dated Oct 23, 2014.