Whitehill Manufacturing Inc
Form 483 issued January 20, 2016 · Stafford, Texas
- Inspection
- Dec 21, 2015 – Jan 20, 2016
- Investigator
- Camerson E. Moore
- Observations
- 10
- Pages
- 5
- FEI number
- 1000118837
In short: On January 20, 2016, FDA issued a Form 483 with 10 observations to Whitehill Manufacturing Inc in Stafford, Texas (FEI 1000118837) after an inspection that ran Dec 21, 2015 – Jan 20, 2016. The investigator was Camerson E. Moore. Most observations concern management controls and production & process controls; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
Management controls and production & process controls account for 7 of 10 observations.
Most cited: 21 CFR 820.25(b) (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
- API Process Equipment - Equipment Maintenance and Cleaning Procedure(s) for maintenance and cleaning of equipment…
- 02
- Laboratory Controls, Expiry and Retest Dating - Stability Monitoring of APIs Confirmation of appropriate storage…
- 03
- Medical Device Process Validation - General A process whose results cannot be fully verified by…
- 04
- Contamination Control Procedure - Medical Device Procedures to prevent contamination of equipment or product by…
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 820.25(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Whitehill Manufacturing Inc?
FDA listed 10 observations on this Form 483, mostly about management controls, production & process controls and facilities & equipment. 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 21, 2015 – Jan 20, 2016. Each investigator has a profile showing what they cite most.
When was Whitehill Manufacturing Inc inspected by FDA?
The inspection ran Dec 21, 2015 – Jan 20, 2016, and the Form 483 is dated January 20, 2016.
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.