Alick's Home Medical Equipment, Inc.
Form 483 issued September 3, 2021 · South Bend, Indiana
- Inspection
- Aug 31 – Sep 3, 2021
- Observations
- 5
- Pages
- 4
- FEI number
- 1000115400
In short: On September 3, 2021, FDA issued a Form 483 with 5 observations to Alick's Home Medical Equipment, Inc. in South Bend, Indiana (FEI 1000115400) after an inspection that ran Aug 31 – Sep 3, 2021. Most observations concern quality system and production.
At a glance
3 of 5 observations on this 483 concern quality system.
What FDA observed
Preview: the opening words of each observation- 01
Batch production and control records do not include complete information relating to the production and…
- 02
Written procedures are not followed for the receipt…
- 03
Complaint procedures are deficient in that written complaint records are not maintained in a file designated…
- 04
The responsibilities and procedures applicable to the quality control unit…
This inspection in context
Questions about this 483
What did FDA find at Alick's Home Medical Equipment, Inc.?
FDA listed 5 observations on this Form 483, mostly about quality system, production and materials. The opening words of each observation are shown on this page.
When was Alick's Home Medical Equipment, Inc. inspected by FDA?
The inspection ran Aug 31 – Sep 3, 2021, and the Form 483 is dated September 3, 2021.
How do I get the full Form 483 for Alick's Home Medical Equipment, 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.