Health Science Products Inc
FDA inspection history in Hueytown, Alabama, 2012 to 2019
- 2
- Form 483s
- 2
- Warning letters
Every document, by year
- Form 483
- Warning letter
2012: one warning letter; 2014: one warning letter; 2017: one Form 483; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2012–14Two warning letters, at Hueytown, Alabama.
- 2017–19Two Form 483s, at Hueytown, Alabama.
- 2019The longest 483 on file: 8 observations over 5 pages at Hueytown, Alabama.
Cited most
Across all Health Science Products observations on file
- 21 CFR 803.17What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?2
- 21 CFR 820.100(a)Corrective and preventive action2
- 21 CFR 820.181Device master record2
- 21 CFR 820.184Device history record2
- 21 CFR 820.198(a)Complaint files2
The complete Health Science Products file.
All 4 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
Hueytown, Alabama
Two Form 483s and two warning letters · 2012 to 2019 · 15 observations
Latest: Form 483, Aug 23, 2019 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-08-23 | 483 Form 483 | Hueytown, Alabama | 8 | $99 |
| 2017-10-30 | 483 Form 483 | Hueytown, Alabama | 7 | $99 |
| 2014-08-27 | Warning letter Warning letter | Hueytown, Alabama | — | $99 |
| 2012-01-12 | Warning letter Warning letter | Hueytown, Alabama | — | $99 |
Investigators on these documents
FEI number 1039621 · most recent document Aug 23, 2019
About Health Science Products Inc
How many FDA Form 483s has Health Science Products Inc received?
FDA Intel has 2 Form 483s on file for Health Science Products Inc; the most recent is dated Aug 23, 2019.
When was Health Science Products Inc last inspected by FDA?
The most recent FDA inspection document on file for Health Science Products Inc is a Form 483 dated Aug 23, 2019, for the site in Hueytown, Alabama.
What did FDA cite at Health Science Products Inc?
The regulations cited most in the observations on file for Health Science Products Inc are 21 CFR 803.17 (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 2 times; 21 CFR 820.100(a) (Corrective and preventive action), 2 times; 21 CFR 820.181 (Device master record), 2 times.
Has Health Science Products Inc received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Health Science Products Inc; the most recent is dated Aug 27, 2014.