Guardian Drug Co. Inc
FDA inspection history in Dayton, New Jersey, 2004 to 2022
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2004: one warning letter; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2004One warning letter, at Dayton, New Jersey.
- 2022One Form 483, at Dayton, New Jersey.
Cited most
Across all Guardian Drug Co. observations on file
- 21 CFR 211.192Production record review2
- 21 CFR 211.160General requirements1
- 21 CFR 211.188Batch production and control records1
- 21 CFR 211.25Personnel qualifications1
- 21 CFR 211.67Equipment cleaning and maintenance1
The complete Guardian Drug Co. 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
Sites
Dayton, New Jersey
One Form 483 and one warning letter · 2004 to 2022 · 7 observations
Latest: Form 483, Feb 17, 2022 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-02-17 | 483 Form 483 | Dayton, New Jersey | 7 | $99 |
| 2004-09-15 | Warning letter Warning letter | Dayton, New Jersey | — | $99 |
Investigators on these documents
FEI number 2245306 · most recent document Feb 17, 2022
About Guardian Drug Co. Inc
How many FDA Form 483s has Guardian Drug Co. Inc received?
FDA Intel has 1 Form 483 on file for Guardian Drug Co. Inc; the most recent is dated Feb 17, 2022.
When was Guardian Drug Co. Inc last inspected by FDA?
The most recent FDA inspection document on file for Guardian Drug Co. Inc is a Form 483 dated Feb 17, 2022, for the site in Dayton, New Jersey.
What did FDA cite at Guardian Drug Co. Inc?
The regulations cited most in the observations on file for Guardian Drug Co. Inc are 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.188 (Batch production and control records), 1 time.
Has Guardian Drug Co. Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Guardian Drug Co. Inc; the most recent is dated Sep 15, 2004.