Pharmacy Creations
FDA inspection history across 3 sites, 2013 to 2023
- 5
- Form 483s
- 1
- Warning letter
- 1
- Response
Every document, by year
- Warning letter
- Form 483
- Response
2013: one 483 response and one Form 483; 2015: one Form 483; 2017: one Form 483; 2019: one Form 483; 2022: one Form 483; 2023: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2013–19Four Form 483s and one 483 response, at Randolph, New Jersey and Ledgewood, New Jersey.
- 2022–23One Form 483 and one warning letter, at Ledgewood, New Jersey and Carlsbad, California.
- 2022The longest 483 on file: 9 observations over 8 pages at Ledgewood, New Jersey.
Cited most
Across all Pharmacy Creations observations on file
- FDCA 501(a)(2)(A)Insanitary conditions7
- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.42Design and construction features3
- 21 CFR 211.166(b)Stability testing2
- 21 CFR 211.165Testing and release for distribution1
The complete Pharmacy Creations file.
All 7 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Ledgewood, New Jersey
Three Form 483s · 2017 to 2022 · 11 observations
Latest: Form 483, Aug 5, 2022 →Randolph, New Jersey
Two Form 483s and one 483 response · 2013 to 2015 · 8 observations
Latest: Form 483, Sep 30, 2015 →Carlsbad, California
One warning letter · 2023
Latest: Warning letter, May 26, 2023 →
Documents
7 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-05-26 | Warning letter Warning letter | Carlsbad, California | — | $99 |
| 2022-08-05 | 483 Form 483 | Ledgewood, New Jersey | 9 | $99 |
| 2019-04-09 | 483 Form 483 | Ledgewood, New Jersey | 1 | $99 |
| 2017-07-10 | 483 Form 483 | Ledgewood, New Jersey | 1 | $99 |
| 2015-09-30 | 483 Form 483 | Randolph, New Jersey | 3 | $99 |
| 2013-09-03 | Response 483 response | Randolph, New Jersey | — | $199 |
| 2013-08-19 | 483 Form 483 | Randolph, New Jersey | 5 | $99 |
Investigators on these documents
Michael R. Klapal (3)Douglas C. Kovacs (2)Jay T. Wong (1)Jose M. Cayuela (1)Nancy F. Scheraga (1)Sena G. Dissmeyer (1)Amy N. Chen (1)Tekalign Wondimu (1)Helen Verdel (1)
FEI number 3003348498 · most recent document May 26, 2023
About Pharmacy Creations
How many FDA Form 483s has Pharmacy Creations received?
FDA Intel has 5 Form 483s on file for Pharmacy Creations; the most recent is dated Aug 5, 2022.
When was Pharmacy Creations last inspected by FDA?
The most recent FDA inspection document on file for Pharmacy Creations is a Form 483 dated Aug 5, 2022, for the site in Ledgewood, New Jersey.
What did FDA cite at Pharmacy Creations?
The regulations cited most in the observations on file for Pharmacy Creations are FDCA 501(a)(2)(A) (Insanitary conditions), 7 times; 21 CFR 211.113 (Control of microbiological contamination), 4 times; 21 CFR 211.42 (Design and construction features), 3 times.
Has Pharmacy Creations received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Pharmacy Creations; the most recent is dated May 26, 2023.