NATIONAL VITAMIN COMPANY
Form 483 issued December 11, 2015 · Casa Grande, Arizona
- Inspection
- Dec 8 – Dec 11, 2015
- Investigators
- Doan T. Nguyen· Vilmary Negron Rodriguez
- Observations
- 5
- Pages
- 5
- FEI number
- 2919114
In short: On December 11, 2015, FDA issued a Form 483 with 5 observations to NATIONAL VITAMIN COMPANY in Casa Grande, Arizona (FEI 2919114) after an inspection that ran Dec 8 – Dec 11, 2015. The investigators were Doan T. Nguyen and Vilmary Negron Rodriguez. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and quality system account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for the cleaning and maintenance of equipment are deficient regarding the protection of clean equipment…
- 02
Written procedures are not followed for the cleaning and maintenance of equipment, including utensils, used in…
- 03
Laboratory records do not include complete records of the periodic…
- 04
Written procedures are not followed for evaluations conducted at least annually to review records associated with…
This inspection in context
Doan T. Nguyen
8 documents · 2014–2019
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Germany.
The firmNATIONAL VITAMIN COMPANY history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67(b)(5)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at NATIONAL VITAMIN COMPANY?
FDA listed 5 observations on this Form 483, mostly about facilities & equipment, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected NATIONAL VITAMIN COMPANY?
Doan T. Nguyen and Vilmary Negron Rodriguez are named on this Form 483, for the inspection of Dec 8 – Dec 11, 2015. Each investigator has a profile showing what they cite most.
When was NATIONAL VITAMIN COMPANY inspected by FDA?
The inspection ran Dec 8 – Dec 11, 2015, and the Form 483 is dated December 11, 2015.
How do I get the full Form 483 for NATIONAL VITAMIN COMPANY?
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.