MasterPharm LLC
FDA inspection history across 2 sites, 2015 to 2021
- 3
- Form 483s
- 2
- Warning letters
Every document, by year
- Warning letter
- Form 483
2015: one Form 483; 2016: one warning letter; 2017: one Form 483; 2020: one Form 483; 2021: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–17Two Form 483s and one warning letter, at Richmond Hill, New York and South Richmond Hill, New York.
- 2020–21One Form 483 and one warning letter, at South Richmond Hill, New York.
- 2020The longest 483 on file: 7 observations over 6 pages at South Richmond Hill, New York.
Cited most
Across all MasterPharm observations on file
- 21 CFR 211.42Design and construction features8
- 21 CFR 211.113Control of microbiological contamination3
- 21 CFR 211.67Equipment cleaning and maintenance2
- 21 CFR 211.165Testing and release for distribution1
- 21 CFR 211.166Stability testing1
The complete MasterPharm file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
South Richmond Hill, New York
Two warning letters and one Form 483 · 2016 to 2021 · 7 observations
Latest: Warning letter, Jul 19, 2021 →Richmond Hill, New York
Two Form 483s · 2015 to 2017 · 8 observations
Latest: Form 483, Jan 30, 2017 →
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-07-19 | Warning letter Warning letter | South Richmond Hill, New York | — | $99 |
| 2020-06-15 | 483 Form 483 | South Richmond Hill, New York | 7 | $99 |
| 2017-01-30 | 483 Form 483 | Richmond Hill, New York | 2 | $99 |
| 2016-01-08 | Warning letter Warning letter | South Richmond Hill, New York | — | $99 |
| 2015-05-06 | 483 Form 483 | Richmond Hill, New York | 6 | $99 |
Investigators on these documents
FEI number 3005734706 · most recent document Jul 19, 2021
About MasterPharm LLC
How many FDA Form 483s has MasterPharm LLC received?
FDA Intel has 3 Form 483s on file for MasterPharm LLC; the most recent is dated Jun 15, 2020.
When was MasterPharm LLC last inspected by FDA?
The most recent FDA inspection document on file for MasterPharm LLC is a Form 483 dated Jun 15, 2020, for the site in South Richmond Hill, New York.
What did FDA cite at MasterPharm LLC?
The regulations cited most in the observations on file for MasterPharm LLC are 21 CFR 211.42 (Design and construction features), 8 times; 21 CFR 211.113 (Control of microbiological contamination), 3 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 2 times.
Has MasterPharm LLC received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for MasterPharm LLC; the most recent is dated Jul 19, 2021.