Pharmaceutics International, Inc.
FDA inspection history across 2 sites, 2016 to 2026
- 6
- Form 483s
- 1
- Warning letter
Every document, by year
- Warning letter
- Form 483
2016: one Form 483; 2017: one Form 483; 2020: two Form 483s; 2021: one Form 483; 2022: one Form 483; 2026: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–17Two Form 483s, at Cockeysville, Maryland.
- 2016The longest 483 on file: 13 observations over 12 pages at Cockeysville, Maryland.
- 2020–22Four Form 483s, at Cockeysville, Maryland.
- 2026One warning letter, at St. Petersburg, Florida.
Cited most
Across all Pharmaceutics International observations on file
- 21 CFR 211.42Design and construction features9
- 21 CFR 211.113Control of microbiological contamination8
- 21 CFR 211.67Equipment cleaning and maintenance6
- 21 CFR 211.100Written procedures; deviations4
- 21 CFR 211.22Responsibilities of quality control unit4
The complete Pharmaceutics International 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
Cockeysville, Maryland
Six Form 483s · 2016 to 2022 · 44 observations
Latest: Form 483, Nov 14, 2022 →St. Petersburg, Florida
One warning letter · 2026
Latest: Warning letter, Aug 27, 2026 →
Documents
7 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2026-08-27 | Warning letter Warning letter | St. Petersburg, Florida | — | $99 |
| 2022-11-14 | 483 Form 483 | Cockeysville, Maryland | 10 | $99 |
| 2021-09-29 | 483 Form 483 | Cockeysville, Maryland | 3 | $99 |
| 2020-10-30 | 483 Form 483 | Cockeysville, Maryland | 5 | $99 |
| 2020-07-10 | 483 Form 483 | Cockeysville, Maryland | 5 | $99 |
| 2017-10-27 | 483 Form 483 | Cockeysville, Maryland | 8 | $99 |
| 2016-04-04 | 483 Form 483 | Cockeysville, Maryland | 13 | $99 |
Investigators on these documents
Robert J. Martin (2)Christina K. Theodorou (1)Deyaa Shaheen (1)Edmund F. Mrak (1)Eric L. Dong (1)Erik W. Koester (1)Jonah S. Ufferfilge (1)Jonathan W. Chapman (1)Junho Pak (1)Kathleen M. Jordan (1)Kristina L. Conroy (1)Marcellinus D. Dordunoo (1)
FEI number 3006503102 · most recent document Aug 27, 2026
About Pharmaceutics International, Inc.
How many FDA Form 483s has Pharmaceutics International, Inc. received?
FDA Intel has 6 Form 483s on file for Pharmaceutics International, Inc.; the most recent is dated Nov 14, 2022.
When was Pharmaceutics International, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Pharmaceutics International, Inc. is a Form 483 dated Nov 14, 2022, for the site in Cockeysville, Maryland.
What did FDA cite at Pharmaceutics International, Inc.?
The regulations cited most in the observations on file for Pharmaceutics International, Inc. are 21 CFR 211.42 (Design and construction features), 9 times; 21 CFR 211.113 (Control of microbiological contamination), 8 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 6 times.
Has Pharmaceutics International, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Pharmaceutics International, Inc.; the most recent is dated Aug 27, 2026.