California Pharmacy & Compounding Center
FDA inspection history in Newport Beach, California, 2014 to 2020
- 7
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2014: two Form 483s; 2015: one warning letter; 2016: one Form 483; 2017: one Form 483; 2018: one amended 483 and one Form 483; 2020: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2014–20Six Form 483s, one warning letter and one amended 483, at Newport Beach, California.
- 2014The longest 483 on file: 15 observations over 14 pages at Newport Beach, California.
Cited most
Across all California Pharmacy & Compounding Center observations on file
- 21 CFR 211.42Design and construction features9
- 21 CFR 211.192Production record review4
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.125(a)Labeling issuance2
- 21 CFR 211.167Special testing requirements2
The complete California Pharmacy & Compounding Center file.
All 8 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Newport Beach, California
Six Form 483s, one amended 483 and one warning letter · 2014 to 2020 · 33 observations
Latest: Form 483, Dec 17, 2020 →
Documents
8 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-12-17 | 483 Form 483 | Newport Beach, California | 1 | $99 |
| 2018-12-18 | Amended 483 Amended 483 | Newport Beach, California | 1 | $99 |
| 2018-12-17 | 483 Form 483 | Newport Beach, California | 1 | $99 |
| 2017-04-21 | 483 Form 483 | Newport Beach, California | 7 | $99 |
| 2016-08-31 | 483 Form 483 | Newport Beach, California | 5 | $99 |
| 2015-06-17 | Warning letter Warning letter | Newport Beach, California | — | $99 |
| 2014-10-17 | 483 Form 483 | Newport Beach, California | 3 | $99 |
| 2014-08-25 | 483 Form 483 | Newport Beach, California | 15 | $99 |
Investigators on these documents
Linda Thai (4)Ademola O. Daramola (2)Binh T. Nguyen (2)Darren S. Brown (1)Liming Zhang (1)
FEI number 3004600090 · most recent document Dec 17, 2020
About California Pharmacy & Compounding Center
How many FDA Form 483s has California Pharmacy & Compounding Center received?
FDA Intel has 7 Form 483s on file for California Pharmacy & Compounding Center; the most recent is dated Dec 17, 2020.
When was California Pharmacy & Compounding Center last inspected by FDA?
The most recent FDA inspection document on file for California Pharmacy & Compounding Center is a Form 483 dated Dec 17, 2020, for the site in Newport Beach, California.
What did FDA cite at California Pharmacy & Compounding Center?
The regulations cited most in the observations on file for California Pharmacy & Compounding Center are 21 CFR 211.42 (Design and construction features), 9 times; 21 CFR 211.192 (Production record review), 4 times; 21 CFR 211.113 (Control of microbiological contamination), 3 times.
Has California Pharmacy & Compounding Center received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for California Pharmacy & Compounding Center; the most recent is dated Jun 17, 2015.