Guardian Pharmacy Services
FDA inspection history across 2 sites, 2016 to 2018
- 3
- Form 483s
- 2
- Responses
Every document, by year
- Response
- Form 483
2016: one Form 483; 2018: two 483 responses and two Form 483s.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–18Three Form 483s and two 483 responses, at Dallas, Texas and Texas.
- 2018The longest 483 on file: 15 observations over 16 pages at Dallas, Texas.
Cited most
Across all Guardian Pharmacy Services observations on file
- 21 CFR 211.42(b)Design and construction features7
- 21 CFR 211.192Production record review5
- 21 CFR 211.113(b)Control of microbiological contamination3
- 21 CFR 211.167(a)Special testing requirements3
- 21 CFR 211.198(a)Complaint files3
The complete Guardian Pharmacy Services file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Dallas, Texas
Three Form 483s · 2016 to 2018 · 38 observations
Latest: Form 483, Apr 23, 2018 →Texas
Two 483 responses · 2018
Latest: Response, Aug 3, 2018 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2018-08-03 | Response 483 response | Texas | — | $199 |
| 2018-04-23 | 483 Form 483 | Dallas, Texas | 15 | $99 |
| 2018-04-20 | 483 Form 483 | Dallas, Texas | 15 | $99 |
| 2018-01-05 | Response 483 response | Texas | — | $199 |
| 2016-10-21 | 483 Form 483 | Dallas, Texas | 8 | $99 |
Investigators on these documents
Bonita S. Chester (2)Patty P. Kaewussdangkul (2)Anh Lac (1)Lori G. Cantin (1)Patrice S. Hall (1)
FEI number 3012669715 · most recent document Aug 3, 2018
About Guardian Pharmacy Services
How many FDA Form 483s has Guardian Pharmacy Services received?
FDA Intel has 3 Form 483s on file for Guardian Pharmacy Services; the most recent is dated Apr 23, 2018.
When was Guardian Pharmacy Services last inspected by FDA?
The most recent FDA inspection document on file for Guardian Pharmacy Services is a Form 483 dated Apr 23, 2018, for the site in Dallas, Texas.
What did FDA cite at Guardian Pharmacy Services?
The regulations cited most in the observations on file for Guardian Pharmacy Services are 21 CFR 211.42(b) (Design and construction features), 7 times; 21 CFR 211.192 (Production record review), 5 times; 21 CFR 211.113(b) (Control of microbiological contamination), 3 times.