PerkinElmer Health Sciences, Inc
Form 483 issued August 1, 2019 · Waltham, Massachusetts
- Inspection
- Aug 1, 2019
- Investigator
- Justine M. Corson
- Observations
- 4
- Pages
- 5
- FEI number
- 3006159931
In short: On August 1, 2019, FDA issued a Form 483 with 4 observations to PerkinElmer Health Sciences, Inc in Waltham, Massachusetts (FEI 3006159931) after an inspection that ran Aug 1, 2019. The investigator was Justine M. Corson. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
Observations span 1 system, led by production & process controls.
Most cited: 21 CFR 820.70 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Premarket Notification was not submitted to the FDA at least 90 days before the introduction into…
- 02
Process control procedures that describe any process controls necessary to ensure conformance to specifications…
- 0321 CFR 820
The Device History Record does not demonstrate that the device was manufactured in accordance with the…
- 04
Software validation activities and results for computers or automated data processing systems used as part of…
This inspection in context
Justine M. Corson
5 documents · 2012–2019
Cites 820.70 (production and process controls) more than any other section. Most of their documents are for sites in Massachusetts.
The firmPerkinElmer Health Sciences, Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.70
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at PerkinElmer Health Sciences, Inc?
FDA listed 4 observations on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.
Who inspected PerkinElmer Health Sciences, Inc?
Justine M. Corson is named on this Form 483, for the inspection of Aug 1, 2019. Each investigator has a profile showing what they cite most.
When was PerkinElmer Health Sciences, Inc inspected by FDA?
The inspection ran Aug 1, 2019, and the Form 483 is dated August 1, 2019.
How do I get the full Form 483 for PerkinElmer Health Sciences, 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.