Pharmaceutics International Inc
FDA inspection history in Hunt Valley, Maryland, 2015 to 2024
- 11
- Form 483s
Every document, by year
- Form 483
2015: one Form 483; 2016: two Form 483s; 2017: two Form 483s; 2018: one Form 483; 2020: two Form 483s; 2021: one Form 483; 2022: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015–2411 Form 483s, at Hunt Valley, Maryland.
- 2017The longest 483 on file: 10 observations over 16 pages at Hunt Valley, Maryland.
Cited most
Across all Pharmaceutics International observations on file
- 21 CFR 211.192Production record review12
- 21 CFR 211.67Equipment cleaning and maintenance8
- 21 CFR 211.160General requirements6
- 21 CFR 211.22Responsibilities of quality control unit6
- 21 CFR 211.68Automatic, mechanical, and electronic equipment6
The complete Pharmaceutics International file.
All 11 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Hunt Valley, Maryland
11 Form 483s · 2015 to 2024 · 52 observations
Latest: Form 483, Dec 6, 2024 →
Documents
11 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-12-06 | 483 Form 483 | Hunt Valley, Maryland | 4 | $99 |
| 2022-11-14 | 483 Form 483 | Hunt Valley, Maryland | 3 | $99 |
| 2021-09-29 | 483 Form 483 | Hunt Valley, Maryland | — | $99 |
| 2020-10-30 | 483 Form 483 | Hunt Valley, Maryland | 4 | $99 |
| 2020-07-10 | 483 Form 483 | Hunt Valley, Maryland | 1 | $99 |
| 2018-11-09 | 483 Form 483 | Hunt Valley, Maryland | 9 | $99 |
| 2017-11-16 | 483 Form 483 | Hunt Valley, Maryland | 10 | $99 |
| 2017-03-24 | 483 Form 483 | Hunt Valley, Maryland | 4 | $99 |
| 2016-03-18 | 483 Form 483 | Hunt Valley, Maryland | 7 | $99 |
| 2016-03-10 | 483 Form 483 | Hunt Valley, Maryland | 7 | $99 |
| 2015-05-22 | 483 Form 483 | Hunt Valley, Maryland | 3 | $99 |
Investigators on these documents
Jonathan W. Chapman (2)Zhongren Wu (2)Edmund F. Mrak (1)James M. Mason (1)James Michael Simpson (1)Junho Pak (1)Kathleen M. Jordan (1)Ko U. Min (1)Chaltu N. Wakijra (1)Marcus A. Ray (1)Nicholas Violand (1)Robert J. Martin (1)
FEI number 1000513101 · most recent document Dec 6, 2024
About Pharmaceutics International Inc
How many FDA Form 483s has Pharmaceutics International Inc received?
FDA Intel has 11 Form 483s on file for Pharmaceutics International Inc; the most recent is dated Dec 6, 2024.
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 Dec 6, 2024, for the site in Hunt Valley, 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 211.192 (Production record review), 12 times; 21 CFR 211.67 (Equipment cleaning and maintenance), 8 times; 21 CFR 211.160 (General requirements), 6 times.