GPC Medical Limited
FDA inspection history on file, 2017 to 2019
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2017: one warning letter; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2017–19One warning letter and one Form 483.
Cited most
Across all GPC Medical Limited observations on file
- 21 CFR 820.70Production and process controls2
- 21 CFR 820.100Corrective and preventive action1
- 21 CFR 820.75Process validation1
- 21 CFR 820.80Receiving, in-process, and finished device acceptance1
The complete GPC Medical Limited file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-10-21 | 483 Form 483 | — | 5 | $99 |
| 2017-10-20 | Warning letter Warning letter | — | — | $99 |
Investigators on these documents
FEI number 3006513362 · most recent document Oct 21, 2019
About GPC Medical Limited
How many FDA Form 483s has GPC Medical Limited received?
FDA Intel has 1 Form 483 on file for GPC Medical Limited; the most recent is dated Oct 21, 2019.
When was GPC Medical Limited last inspected by FDA?
The most recent FDA inspection document on file for GPC Medical Limited is a Form 483 dated Oct 21, 2019.
What did FDA cite at GPC Medical Limited?
The regulations cited most in the observations on file for GPC Medical Limited are 21 CFR 820.70 (Production and process controls), 2 times; 21 CFR 820.100 (Corrective and preventive action), 1 time; 21 CFR 820.75 (Process validation), 1 time.
Has GPC Medical Limited received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for GPC Medical Limited; the most recent is dated Oct 20, 2017.