Whitehill Manufacturing Inc
Form 483 issued December 21, 2015 · Stafford, Texas
- Inspection
- Dec 9 – Dec 21, 2015
- Investigator
- Camerson E. Moore
- Observations
- 7
- Pages
- 4
- FEI number
- 1000118837
In short: On December 21, 2015, FDA issued a Form 483 with 7 observations to Whitehill Manufacturing Inc in Stafford, Texas (FEI 1000118837) after an inspection that ran Dec 9 – Dec 21, 2015. The investigator was Camerson E. Moore. Most observations concern production & process controls and management controls; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
Production & process controls and management controls account for 6 of 7 observations.
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
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Procedures to prevent contamination of equipment or product by substances that may have an adverse effect…
- 03
Procedures have not been adequately established to control product that does not…
- 04
Procedures for changes to a specification and method and process have…
This inspection in context
Camerson E. Moore
48 documents · 2014–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmWhitehill Manufacturing 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 Whitehill Manufacturing Inc?
FDA listed 7 observations on this Form 483, mostly about production & process controls, management controls and cAPA. 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 Whitehill Manufacturing Inc?
Camerson E. Moore is named on this Form 483, for the inspection of Dec 9 – Dec 21, 2015. Each investigator has a profile showing what they cite most.
When was Whitehill Manufacturing Inc inspected by FDA?
The inspection ran Dec 9 – Dec 21, 2015, and the Form 483 is dated December 21, 2015.
How do I get the full Form 483 for Whitehill Manufacturing 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.