Chen Shwezin Inc. dba Park Compounding Pharmacy
FDA inspection history in Westlake Village, California, 2015 to 2020
- 2
- Form 483s
- 1
- Close-out
Every document, by year
- Close-out
- Form 483
2015: one Form 483; 2018: one Form 483; 2020: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One Form 483, at Westlake Village, California.
- 2015The longest 483 on file: 10 observations over 7 pages at Westlake Village, California.
- 2018–20One Form 483 and one close-out letter, at Westlake Village, California.
Cited most
Across all Chen Shwezin Inc. dba Park Compounding Pharmacy observations on file
- 21 CFR 211.42(c)Design and construction features5
- 21 CFR 211.113Control of microbiological contamination2
- 21 CFR 211.137(a)Expiration dating1
- 21 CFR 211.160General requirements1
- 21 CFR 211.165Testing and release for distribution1
The complete Chen Shwezin Inc. dba Park Compounding Pharmacy file.
All 3 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
Westlake Village, California
Two Form 483s and one close-out letter · 2015 to 2020 · 15 observations
Latest: Close-out, Jul 20, 2020 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-07-20 | Close-out Close-out letter | Westlake Village, California | — | $99 |
| 2018-04-03 | 483 Form 483 | Westlake Village, California | 5 | $99 |
| 2015-10-05 | 483 Form 483 | Westlake Village, California | 10 | $99 |
Investigators on these documents
FEI number 3005256616 · most recent document Jul 20, 2020
About Chen Shwezin Inc. dba Park Compounding Pharmacy
How many FDA Form 483s has Chen Shwezin Inc. dba Park Compounding Pharmacy received?
FDA Intel has 2 Form 483s on file for Chen Shwezin Inc. dba Park Compounding Pharmacy; the most recent is dated Apr 3, 2018.
When was Chen Shwezin Inc. dba Park Compounding Pharmacy last inspected by FDA?
The most recent FDA inspection document on file for Chen Shwezin Inc. dba Park Compounding Pharmacy is a Form 483 dated Apr 3, 2018, for the site in Westlake Village, California.
What did FDA cite at Chen Shwezin Inc. dba Park Compounding Pharmacy?
The regulations cited most in the observations on file for Chen Shwezin Inc. dba Park Compounding Pharmacy are 21 CFR 211.42(c) (Design and construction features), 5 times; 21 CFR 211.113 (Control of microbiological contamination), 2 times; 21 CFR 211.137(a) (Expiration dating), 1 time.