Professional Disposables International, Inc.
FDA inspection history across 2 sites, 2006 to 2022
- 8
- Form 483s
- 1
- Warning letter
- 1
- Close-out
Every document, by year
- Warning letter
- Form 483
- Close-out
2006: one Form 483; 2008: two Form 483s; 2010: one Form 483; 2011: two Form 483s; 2019: one Form 483; 2021: one Form 483; 2022: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2006–11Six Form 483s, at Orangeburg, New York.
- 2019–22Two Form 483s and one warning letter, at Orangeburg, New York.
- 2019The longest 483 on file: 12 observations over 10 pages at Orangeburg, New York.
Cited most
Across all Professional Disposables International observations on file
- 21 CFR 211.160General requirements5
- 21 CFR 211.192Production record review5
- 21 CFR 211.100Written procedures; deviations4
- 21 CFR 211.142Warehousing procedures3
- 21 CFR 211.180General requirements2
The complete Professional Disposables International file.
All 10 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
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Sites
Orangeburg, New York
Eight Form 483s and one warning letter · 2006 to 2022 · 35 observations
Latest: Warning letter, Jan 7, 2022 →Miami Beach, Florida
One close-out letter
Latest: Close-out, — →
Documents
10 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-01-07 | Warning letter Warning letter | Orangeburg, New York | — | $99 |
| 2021-06-23 | 483 Form 483 | Orangeburg, New York | 8 | $99 |
| 2019-05-28 | 483 Form 483 | Orangeburg, New York | 12 | $99 |
| 2011-07-05 | 483 Form 483 | Orangeburg, New York | 2 | $99 |
| 2011-04-20 | 483 Form 483 | Orangeburg, New York | 2 | $99 |
| 2010-10-21 | 483 Form 483 | Orangeburg, New York | 3 | $99 |
| 2008-10-29 | 483 Form 483 | Orangeburg, New York | 4 | $99 |
| 2008-08-12 | 483 Form 483 | Orangeburg, New York | 3 | $99 |
| 2006-12-18 | 483 Form 483 | Orangeburg, New York | 1 | $99 |
| Undated | Close-out Close-out letter | Miami Beach, Florida | — | $99 |
Investigators on these documents
Alice S. Tsao (1)Demitria J. Argiropoulos (1)Jone E. Pins (1)Lata Mathew (1)Paul C. Mouris (1)Sony Mathews (1)Sony Pljathews (1)Vivin George (1)
FEI number 2411192 · most recent document Jan 7, 2022
About Professional Disposables International, Inc.
How many FDA Form 483s has Professional Disposables International, Inc. received?
FDA Intel has 8 Form 483s on file for Professional Disposables International, Inc.; the most recent is dated Jun 23, 2021.
When was Professional Disposables International, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Professional Disposables International, Inc. is a Form 483 dated Jun 23, 2021, for the site in Orangeburg, New York.
What did FDA cite at Professional Disposables International, Inc.?
The regulations cited most in the observations on file for Professional Disposables International, Inc. are 21 CFR 211.160 (General requirements), 5 times; 21 CFR 211.192 (Production record review), 5 times; 21 CFR 211.100 (Written procedures; deviations), 4 times.
Has Professional Disposables International, Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Professional Disposables International, Inc.; the most recent is dated Jan 7, 2022.