Medical Components, Inc dba MedComp
FDA inspection history in Harleysville, Pennsylvania, 2015
- 1
- Close-out
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Close-out
- Warning letter
- Form 483
2015: one close-out letter, one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One close-out letter, one warning letter and one Form 483, at Harleysville, Pennsylvania.
Cited most
Across all Medical Components, Inc dba MedComp observations on file
- 21 CFR 820.50Purchasing controls2
- 21 CFR 211.166Stability testing1
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 806.10Reports of corrections and removals1
- 21 CFR 820.100Corrective and preventive action1
The complete Medical Components, Inc dba MedComp file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Harleysville, Pennsylvania
One close-out letter, one warning letter and one Form 483 · 2015 · 12 observations
Latest: Close-out, Oct 14, 2015 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-10-14 | Close-out Close-out letter | Harleysville, Pennsylvania | — | $99 |
| 2015-04-02 | Warning letter Warning letter | Harleysville, Pennsylvania | — | $99 |
| 2015-02-12 | 483 Form 483 | Harleysville, Pennsylvania | 12 | $99 |
Investigators on these documents
FEI number 2518902 · most recent document Oct 14, 2015
About Medical Components, Inc dba MedComp
How many FDA Form 483s has Medical Components, Inc dba MedComp received?
FDA Intel has 1 Form 483 on file for Medical Components, Inc dba MedComp; the most recent is dated Feb 12, 2015.
When was Medical Components, Inc dba MedComp last inspected by FDA?
The most recent FDA inspection document on file for Medical Components, Inc dba MedComp is a Form 483 dated Feb 12, 2015, for the site in Harleysville, Pennsylvania.
What did FDA cite at Medical Components, Inc dba MedComp?
The regulations cited most in the observations on file for Medical Components, Inc dba MedComp are 21 CFR 820.50 (Purchasing controls), 2 times; 21 CFR 211.166 (Stability testing), 1 time; 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time.
Has Medical Components, Inc dba MedComp received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Medical Components, Inc dba MedComp; the most recent is dated Apr 2, 2015.