Leiter's Compounding Pharmacy
FDA inspection history across 3 sites, 2013 to 2025
- 7
- Form 483s
- 6
- Responses
- 1
- Untitled letter
- 1
- Warning letter
Every document, by year
- Form 483
- Response
- Untitled letter
- Warning letter
2013: one 483 response; 2014: two Form 483s and one 483 response; 2016: one warning letter; 2017: one Form 483; 2018: one Form 483; 2021: one Form 483; 2023: one 483 response and one Form 483; 2024: three untitled letter responses and one untitled letter; 2025: one amended 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2013–18Four Form 483s, two 483 responses and one warning letter, at San Jose, California and San Jo se, California.
- 2014The longest 483 on file: 9 observations over 5 pages at San Jo se, California.
- 2021–25Three untitled letter responses, two Form 483s, one 483 response, one untitled letter and one amended 483, at San Jose, California and California.
Cited most
Across all Leiter's Compounding Pharmacy observations on file
- 21 CFR 211.113(b)Control of microbiological contamination5
- 21 CFR 211.42(c)Design and construction features5
- 21 CFR 211.22(a)Responsibilities of quality control unit4
- 21 CFR 211.192Production record review3
- 21 CFR 211.25(a)Personnel qualifications3
The complete Leiter's Compounding Pharmacy file.
All 15 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
San Jose, California
Four Form 483s, two 483 responses, one amended 483, one untitled letter response, one untitled letter and one warning letter · 2013 to 2025 · 21 observations
Latest: Form 483, Jul 3, 2025 →California
Two untitled letter responses and one 483 response · 2023 to 2024
Latest: Response, Jul 30, 2024 →San Jo se, California
Two Form 483s · 2014 · 13 observations
Latest: Form 483, Oct 7, 2014 →
Documents
15 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-07-03 | Amended 483 Amended 483 | San Jose, California | 3 | $99 |
| 2024-07-30 | Response Untitled letter response | California | — | $199 |
| 2024-06-27 | Response Untitled letter response | California | — | $199 |
| 2024-05-24 | Response Untitled letter response | San Jose, California | — | $199 |
| 2024-04-25 | Untitled letter Untitled letter | San Jose, California | — | $99 |
| 2023-12-07 | Response 483 response | California | — | $199 |
| 2023-11-17 | 483 Form 483 | San Jose, California | 8 | $99 |
| 2021-12-03 | 483 Form 483 | San Jose, California | 4 | $99 |
| 2018-12-19 | 483 Form 483 | San Jose, California | 3 | $99 |
| 2017-06-15 | 483 Form 483 | San Jose, California | 3 | $99 |
| 2016-02-29 | Warning letter Warning letter | San Jose, California | — | $99 |
| 2014-10-07 | 483 Form 483 | San Jo se, California | 4 | $99 |
| 2014-03-26 | Response 483 response | San Jose, California | — | $199 |
| 2014-03-06 | 483 Form 483 | San Jo se, California | 9 | $99 |
| 2013-11-25 | Response 483 response | San Jose, California | — | $199 |
Investigators on these documents
Anh Lac (3)Jolanna A. Norton (2)Henry K. Lau (2)Ashar P. Parikh (2)Jennifer H. Rhyu (1)Lisa Shin (1)Matthew R. Clabeaux (1)Alicia K. McKinsey (1)Thomas J. Arista (1)Andrew Le (1)Anney Lin (1)Jeffrey P. Raimondi (1)
FEI number 3003434972 · most recent document Jul 3, 2025
About Leiter's Compounding Pharmacy
How many FDA Form 483s has Leiter's Compounding Pharmacy received?
FDA Intel has 7 Form 483s on file for Leiter's Compounding Pharmacy; the most recent is dated Jul 3, 2025.
When was Leiter's Compounding Pharmacy last inspected by FDA?
The most recent FDA inspection document on file for Leiter's Compounding Pharmacy is a Form 483 dated Jul 3, 2025, for the site in San Jose, California.
What did FDA cite at Leiter's Compounding Pharmacy?
The regulations cited most in the observations on file for Leiter's Compounding Pharmacy are 21 CFR 211.113(b) (Control of microbiological contamination), 5 times; 21 CFR 211.42(c) (Design and construction features), 5 times; 21 CFR 211.22(a) (Responsibilities of quality control unit), 4 times.
Has Leiter's Compounding Pharmacy received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Leiter's Compounding Pharmacy; the most recent is dated Feb 29, 2016.
Has Leiter's Compounding Pharmacy received an FDA untitled letter?
Yes. FDA Intel has 1 FDA untitled letter on file for Leiter's Compounding Pharmacy; the most recent is dated Apr 25, 2024. An untitled letter is FDA's enforcement letter for violations that don't rise to warning-letter level.