Home Intensive Care Pharmacy, Inc.

Form 483 issued December 20, 2002 · Arlington, Virginia

Inspection
Dec 20, 2002
Investigator
Lida D. Cato
Observations
13
Pages
45
FEI number
1000123507

In short: On December 20, 2002, FDA issued a Form 483 with 13 observations to Home Intensive Care Pharmacy, Inc. in Arlington, Virginia (FEI 1000123507) after an inspection that ran Dec 20, 2002. The investigator was Lida D. Cato. Most observations concern biologics CGMP; the most-cited regulation is 21 CFR 606.160 (records).

At a glance

3 of 3 observations on this 483 concern biologics cgmp.

Biologics CGMP3

Most cited: 21 CFR 606.160 (3×)

What FDA observed

Preview: the opening words of each observation

Dashed: section inferred by FDA Intel and checked against the regulation text

  1. 01

    On 10/6/00, the Vice President of Quality Assurance (QA) submitted a potential system problem. The records…

  2. 02

    After closure of the system problem #511 and without BHQ taking any system-wide corrective action fallegations…

  3. 03

    A special audit was conducted in August 2001 when the region’s management notified…

10 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

Questions about this 483

What did FDA find at Home Intensive Care Pharmacy, Inc.?

FDA listed 13 observations on this Form 483, mostly about biologics CGMP. The most-cited regulation is 21 CFR 606.160 (records). The opening words of each observation are shown on this page.

Who inspected Home Intensive Care Pharmacy, Inc.?

Lida D. Cato is named on this Form 483, for the inspection of Dec 20, 2002. Each investigator has a profile showing what they cite most.

When was Home Intensive Care Pharmacy, Inc. inspected by FDA?

The inspection ran Dec 20, 2002, and the Form 483 is dated December 20, 2002.

How do I get the full Form 483 for Home Intensive Care Pharmacy, 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.

$99Get it free