ErgoMed, Inc
FDA inspection history in San Antonio, Texas, 2022
- 1
- Form 483
Every document, by year
- Form 483
2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2022One Form 483, at San Antonio, Texas.
Cited most
Across all ErgoMed observations on file
- 21 CFR 803.17(a)(1)What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 820.22Quality audit1
- 21 CFR 820.40Document controls1
- 21 CFR 820.50Purchasing controls1
- 21 CFR 820.80(a)Receiving, in-process, and finished device acceptance1
The complete ErgoMed file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
San Antonio, Texas
One Form 483 · 2022 · 6 observations
Latest: Form 483, Oct 5, 2022 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-10-05 | 483 Form 483 | San Antonio, Texas | 6 | $99 |
Investigators on these documents
FEI number 1000306115 · most recent document Oct 5, 2022
About ErgoMed, Inc
How many FDA Form 483s has ErgoMed, Inc received?
FDA Intel has 1 Form 483 on file for ErgoMed, Inc; the most recent is dated Oct 5, 2022.
When was ErgoMed, Inc last inspected by FDA?
The most recent FDA inspection document on file for ErgoMed, Inc is a Form 483 dated Oct 5, 2022, for the site in San Antonio, Texas.
What did FDA cite at ErgoMed, Inc?
The regulations cited most in the observations on file for ErgoMed, Inc are 21 CFR 803.17(a)(1) (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 820.22 (Quality audit), 1 time; 21 CFR 820.40 (Document controls), 1 time.