Medline Industries Holdings LP
Form 483 issued May 1, 2015 · Laredo, Texas
- Inspection
- May 27 – Jun 1, 2015
- Investigators
- Arie C. Menachem· Carlos Chavez· Melissa G. Gonzalez
- Observations
- 9
- Pages
- 4
- FEI number
- 3005595283
In short: On May 1, 2015, FDA issued a Form 483 with 9 observations to Medline Industries Holdings LP in Laredo, Texas (FEI 3005595283) after an inspection that ran May 27 – Jun 1, 2015. The investigators were Arie C. Menachem, Carlos Chavez and Melissa G. Gonzalez. Most observations concern production & process controls and cAPA.
At a glance
7 of 9 observations on this 483 concern production & process controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for corrective and preventive action have…
- 02
Requirements that must be met by contractors…
- 03
Procedures for product handling…
- 04
Procedures for quality audits have…
This inspection in context
Arie C. Menachem
5 documents · 2015–2018
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmMedline Industries Holdings LP history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medline Industries Holdings LP?
FDA listed 9 observations on this Form 483, mostly about production & process controls, cAPA and management controls. The opening words of each observation are shown on this page.
Who inspected Medline Industries Holdings LP?
Arie C. Menachem, Carlos Chavez and Melissa G. Gonzalez are named on this Form 483, for the inspection of May 27 – Jun 1, 2015. Each investigator has a profile showing what they cite most.
When was Medline Industries Holdings LP inspected by FDA?
The inspection ran May 27 – Jun 1, 2015, and the Form 483 is dated May 1, 2015.
How do I get the full Form 483 for Medline Industries Holdings LP?
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.