Forcemech International LLC
FDA inspection history in Pearland, Texas, 2021 to 2022
- 1
- Warning letter
- 1
- Form 483
- 1
- Close-out
Every document, by year
- Warning letter
- Form 483
- Close-out
2021: one Form 483; 2022: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2021–22One Form 483 and one warning letter, at Pearland, Texas.
Cited most
Across all Forcemech International observations on file
- 21 CFR 820.90(a)Nonconforming product2
- 21 CFR 803.17(a)(2)What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.198(a)Complaint files1
- 21 CFR 820.20(c)Management responsibility1
The complete Forcemech International 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
Pearland, Texas
One warning letter, one Form 483 and one close-out letter · 2021 to 2022 · 11 observations
Latest: Warning letter, Sep 21, 2022 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-09-21 | Warning letter Warning letter | Pearland, Texas | — | $99 |
| 2021-04-16 | 483 Form 483 | Pearland, Texas | 11 | $99 |
| Undated | Close-out Close-out letter | Pearland, Texas | — | $99 |
Investigators on these documents
FEI number 3013934051 · most recent document Sep 21, 2022
About Forcemech International LLC
How many FDA Form 483s has Forcemech International LLC received?
FDA Intel has 1 Form 483 on file for Forcemech International LLC; the most recent is dated Apr 16, 2021.
When was Forcemech International LLC last inspected by FDA?
The most recent FDA inspection document on file for Forcemech International LLC is a Form 483 dated Apr 16, 2021, for the site in Pearland, Texas.
What did FDA cite at Forcemech International LLC?
The regulations cited most in the observations on file for Forcemech International LLC are 21 CFR 820.90(a) (Nonconforming product), 2 times; 21 CFR 803.17(a)(2) (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 820.100(a) (Corrective and preventive action), 1 time.
Has Forcemech International LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Forcemech International LLC; the most recent is dated Sep 21, 2022.