King Brand Healthcare Products Ltd
Form 483 issued January 21, 2016 · Collingwood, Canada
- Inspection
- Jan 18 – Jan 21, 2016
- Investigator
- Thomas A. Peter
- Observations
- 7
- Pages
- 9
- FEI number
- 3008467558
In short: On January 21, 2016, FDA issued a Form 483 with 7 observations to King Brand Healthcare Products Ltd in Collingwood, Canada (FEI 3008467558) after an inspection that ran Jan 18 – Jan 21, 2016. The investigator was Thomas A. Peter. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Production & process controls and capa account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures to ensme sampling methods are adequate for then intended use…
- 02
Procedures for acceptance of incoming product have…
- 03
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 04
Procedures for corrective and preventive action have…
This inspection in context
Thomas A. Peter
9 documents · 2011–2019
Cites 820.30(a) (design controls) more than any other section. Most of their documents are for sites in Indiana.
The firmKing Brand Healthcare Products Ltd history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.250(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at King Brand Healthcare Products Ltd?
FDA listed 7 observations on this Form 483, mostly about production & process controls, cAPA and design controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected King Brand Healthcare Products Ltd?
Thomas A. Peter is named on this Form 483, for the inspection of Jan 18 – Jan 21, 2016. Each investigator has a profile showing what they cite most.
When was King Brand Healthcare Products Ltd inspected by FDA?
The inspection ran Jan 18 – Jan 21, 2016, and the Form 483 is dated January 21, 2016.
How do I get the full Form 483 for King Brand Healthcare Products Ltd?
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.