Health Science Products Inc
Form 483 issued August 23, 2019 · Hueytown, Alabama
- Inspection
- Apr 16 – Aug 23, 2019
- Investigator
- Wendy R. Blame
- Observations
- 8
- Pages
- 5
- FEI number
- 1039621
In short: On August 23, 2019, FDA issued a Form 483 with 8 observations to Health Science Products Inc in Hueytown, Alabama (FEI 1039621) after an inspection that ran Apr 16 – Aug 23, 2019. The investigator was Wendy R. Blame. Most observations concern cAPA and records & documents.
At a glance
CAPA and records & documents account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
Written MDR procedures have not been…
- 02
Procedures for corrective and preventive action…
- 03
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit…
- 04
A device master record…
This inspection in context
Wendy R. Blame
2 documents · 2017–2019
Cites 803.17 (what are the requirements for developing, maintaining, and implementing written mdr procedures that apply to me?) more than any other section. Most of their documents are for sites in Alabama.
The firmHealth Science Products Inc history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 803.17
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Health Science Products Inc?
FDA listed 8 observations on this Form 483, mostly about cAPA, records & documents and management controls. The opening words of each observation are shown on this page.
Who inspected Health Science Products Inc?
Wendy R. Blame is named on this Form 483, for the inspection of Apr 16 – Aug 23, 2019. Each investigator has a profile showing what they cite most.
When was Health Science Products Inc inspected by FDA?
The inspection ran Apr 16 – Aug 23, 2019, and the Form 483 is dated August 23, 2019.
How do I get the full Form 483 for Health Science Products 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.