Auro Pharmacies, Inc.
FDA inspection history across 2 sites, 2015 to 2022
- 3
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2015: one Form 483; 2016: one warning letter; 2018: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–18Two Form 483s and one warning letter, at La Hab r a, California and La Habra, California.
- 2018The longest 483 on file: 10 observations over 9 pages at La Habra, California.
- 2022One Form 483, at La Habra, California.
Cited most
Across all Auro Pharmacies observations on file
- 21 CFR 211.113Control of microbiological contamination5
- 21 CFR 211.42Design and construction features4
- 21 CFR 211.166Stability testing3
- 21 CFR 211.192Production record review3
- 21 CFR 211.160General requirements2
The complete Auro Pharmacies 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
La Habra, California
Two Form 483s and one warning letter · 2016 to 2022 · 12 observations
Latest: Form 483, Aug 12, 2022 →La Hab r a, California
One Form 483 · 2015 · 9 observations
Latest: Form 483, Nov 5, 2015 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-08-12 | 483 Form 483 | La Habra, California | 2 | $99 |
| 2018-07-09 | 483 Form 483 | La Habra, California | 10 | $99 |
| 2016-12-13 | Warning letter Warning letter | La Habra, California | — | $99 |
| 2015-11-05 | 483 Form 483 | La Hab r a, California | 9 | $99 |
Investigators on these documents
Andrew K. Haack (1)Bryan A. Galvez (1)Kenneth O. Gee (1)Uttaniti Limchumroon (1)
FEI number 3011893599 · most recent document Aug 12, 2022
About Auro Pharmacies, Inc.
How many FDA Form 483s has Auro Pharmacies, Inc. received?
FDA Intel has 3 Form 483s on file for Auro Pharmacies, Inc.; the most recent is dated Aug 12, 2022.
When was Auro Pharmacies, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Auro Pharmacies, Inc. is a Form 483 dated Aug 12, 2022, for the site in La Habra, California.
What did FDA cite at Auro Pharmacies, Inc.?
The regulations cited most in the observations on file for Auro Pharmacies, Inc. are 21 CFR 211.113 (Control of microbiological contamination), 5 times; 21 CFR 211.42 (Design and construction features), 4 times; 21 CFR 211.166 (Stability testing), 3 times.
Has Auro Pharmacies, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Auro Pharmacies, Inc.; the most recent is dated Dec 13, 2016.